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Phase IIa Trial of Anti-CD19 CAR T-Cells in Systemic Sclerosis Resistant to Immunosuppressive Therapy (SCLEROCAR) Phase 2 6 Cell Therapy
Clinical Trial NCT07493395 (SCLEROCAR) is designed to study Treatment for Scleroderma, Systemic. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 6 participants. Led by University Hospital, Montpellier, this study is expected to complete by 1 April 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
The goal of this clinical trial is to evaluate whether anti-CD19 CAR T-cell therapy can improve disease activity in adults with severe, treatment-resistant systemic sclerosis (SSc). The study will also assess the safety of this therapy and how CAR T-cells behave in the body.
The main questions are:
Does CAR T-cell therapy reduce skin thickening and other signs of SSc? What side effects occur after receiving CAR T-c...
Show MoreDetailed Description
Systemic sclerosis (SSc) is a rare and severe autoimmune disease characterized by fibrosis of the skin and multiple organs, vasculopathy, and immune dysregulation. Many patients continue to experience active and progressive disease despite conventional immunosuppressive treatments, including disease modifying antirheumatic drugs (DMARDs) and biologics. Therapeutic options remain limited, and there is a significant un...Show More
Official Title
SCLEROCAR: A Phase IIa Trial Evaluating the Efficacy of Anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs
Conditions
Scleroderma, SystemicOther Study IDs
- SCLEROCAR
- RECHMPL24_0438
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-04-01
Enrollment (Estimated)
6
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Systemic Sclerosis
Anti-CD19 CAR T-cells
Autologous CAR T-cell therapy
Anti-CD19 CAR T-cells
Autologous CAR T-cell therapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCD19 CAR T Arm Participants assigned to this arm will undergo leukapheresis and receive a lymphodepleting chemotherapy regimen, followed by a single intravenous infusion of autologous anti-CD19 CAR T-cells on Day 0. All participants enrolled in the study are included in this single experimental arm | CD19 CAR T Arm Autologous anti-CD19 CAR-T cells are generated from the participant's leukapheresis product in a Good Manufacturing Practice (GMP)-certified facility using a lentiviral vector.
Prior to infusion, participants will receive a short course of lymphodepleting chemotherapy.
A single intravenous infusion of autologous anti-CD19 CAR-T cells will be administered on Day 0 at a target dose of 1 × 10⁶ CAR-T cells/kg. Particip...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 6 Months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | From 3 months to 1 month before CAR-T cell infusion |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | 1 month before CAR-T cell infusion |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | Day 0 (CAR-T cell infusion) |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | Day 28 after CAR-T cell infusion |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | 3 Months |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | 6 Months |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | 12 Months |
Change in European Scleroderma Trial And Research (EUSTAR) activity index | Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) \>18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein \>1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted \<70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease | 24 Months |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | From 3 months to 1 month before CAR-T infusion |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 1 month before CAR-T infusion |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | Day 0 (CAR-T infusion) |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | Day 28 after infusion |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 2 Months |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 3 Months |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 6 Months |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 12 months |
modified Rodnan skin score (mRSS) | Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis) | 24 months |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | From 3 months to 1 month before CAR-T infusion |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 1 month before CAR-T infusion |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | Day 0 (CAR-T infusion) |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | Day 28 after infusion |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 2 Months |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 3 Months |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 6 Months |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 12 Months |
Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) | Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).
The rCRISS is a 2-step composite score:
Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% \<80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.
Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.
Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score | 24 Months |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | From 3 months to 1 month before CAR-T infusion |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | 1 month before CAR-T infusion |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | 3 Months |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | 6 Months |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | 12 Months |
Change in the lung capacity FVC (forced vital capacity) | To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time | 24 Months |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | From 3 months to 1 month before CAR-T infusion |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | 1 month before CAR-T infusion |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | 3 Months |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | 6 Months |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | 12 Months |
Change in DLCO (diffusing capacity of the lung for carbon monoxide) | The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab | 24 Months |
Extent of fibrosis on pulmonary CT (Computed Tomography) | Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb) | From 3 months to 1 month before CAR-T infusion |
Extent of fibrosis on pulmonary CT(Computed Tomography) | Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb) | 3 Months |
Extent of fibrosis on pulmonary CT(Computed Tomography) | Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb) | 12 Months |
Extent of fibrosis on pulmonary CT(Computed Tomography) | Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb) | 24 Months |
Change in cardiac ejection fraction and global longitudinal strain | A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS). | From 3 months to 1 month before CAR-T infusion |
Change in cardiac ejection fraction and global longitudinal strain | A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS). | 3 Months |
Change in cardiac ejection fraction and global longitudinal strain | A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS). | 12 Months |
Change in cardiac ejection fraction and global longitudinal strain | A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS). | 24 Months |
Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal | A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension | From 3 months to 1 month before CAR-T infusion |
Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal | A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension | 12 Months |
Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal | A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension | 24 Months |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | Day 0 (CAR-T infusion) |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | Day 28 after CAR-T cell infusion |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | 3 Months |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | 6 Months |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | 12 Months |
Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score | Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage | 24 Months |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | Day 0 (CAR-T cell infusion) |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | Day 28 after CAR-T cell infusion |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | 3 Months |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | 6 Months |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | 12 Months |
Change in Health Assessment Questionnaire Disability Index HAQ-DI score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage | 24 Months |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | Day 0 (CAR-T cell infusion) |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | Day 28 after CAR-T cell infusion |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | 3 Months |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | 6 Months |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | 12 Months |
Change in Health Assessment Questionnaire Cochin Hand score | Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment. | 24 Months |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the SF36 self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | Day 0 (CAR-T cell infusion) |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | Day 28 after CAR-T cell infusion |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | 3 Months |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | 6 Months |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | 12 Months |
Change in quality of life Questionnaire SF-36 | Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health | 24 Months |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | Day 0 (CAR-T cell infusion) |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | Day 28 after CAR-T cell infusion |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | 3 Months |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | 6 Months |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | 12 Months |
Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score | to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point | 24 Months |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | From 3 months to 1 month before CAR-T cell infusion |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | 1 month before CAR-T cell infusion |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | Day 0 (CAR-T cell infusion) |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | Day 28 after CAR-T cell infusion |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | 3 Months |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | 6 Months |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | 12 Months |
Change in Malnutrition Universal Screening Tool (MUST) score | We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake | 24 Months |
Anti-antibody titers | Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration | From 3 months to 1 month before CAR-T cell infusion |
Anti-antibody titers | Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration | Day 28 after CAR-T cell infusion |
Anti-antibody titers | Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration | 6 Months |
Anti-antibody titers | Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration | 12 Months |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 0 (CAR-T cell infusion) |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 4 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 7 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 10 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 14 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 21 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | Day 28 after CAR-T cell infusion |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | 3 Months |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | 6 Months |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | 12 Months |
CAR T cell counts | Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion | 24 Months |
Immunophenotyping of B, T, and NK cells subsets | Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion | Day -14 (14 days before CAR-T infusion) |
Immunophenotyping of B, T, and NK cells subsets | Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion | Day 28 after CAR-T cell infusion |
Immunophenotyping of B, T, and NK cells subsets | Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion | 3 Months |
Immunophenotyping of B, T, and NK cells subsets | Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion | 6 Months |
Immunophenotyping of B, T, and NK cells subsets | Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion | 12 Months |
B-cell receptor (BCR) repertoire analysis | BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is \>50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration | Day -14 (14 days before CAR-T infusion) |
B-cell receptor (BCR) repertoire analysis | BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is \>50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration | 6 Months |
B-cell receptor (BCR) repertoire analysis | BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is \>50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration | 12 Months |
B-cell receptor (BCR) repertoire analysis | BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is \>50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration | 24 Months |
Skin biopsies for single-cell phenotyping | Skin biopsies (for patients who have given their consent) performed at baseline for single-cell phenotyping analyses. | From 3 months to 1 month before CAR-T infusion |
Skin biopsies for single-cell phenotyping | Skin biopsies (for patients who have given their consent) performed at M3 for single-cell phenotyping analyses. | 3 Months |
lymph node biopsies for single-cell phenotyping | lymph node biopsies (for patients who have given their consent) performed at Month 3 for single-cell phenotyping analyses. | 3 Months |
Incidence rate of adverse events | Incidence rate of adverse events graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and classified following the American Society of Clinical Oncology (ASCO) guidelines | Day -14 to 24 months |
Incidence of Cytokine Release Syndrome (CRS) | Incidence and severity of Cytokine Release Syndrome (CRS), graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system. | Day -14 to 24 months |
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | Incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system | Day -14 to 24 months |
Incidence of Cytopenias | Incidence and severity of cytopenias, graded according to the consensus grading system of the European Hematology Association (EHA) and the European Society for Blood and Marrow Transplantation (EBMT) consensus grading system | Day -14 to 24 months |
Incidence of Infections | Incidence and severity of infections, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. | Day -14 to 24 months |
Incidence of Cardiac Events | Incidence and severity of cardiac adverse events, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. | Day -14 to 24 months |
Incidence of Acute Kidney Injury | Incidence and severity of acute kidney injury, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. | Day -14 to 24 months |
Incidence of Scleroderma Renal Crisis | Incidence of clinically diagnosed scleroderma renal crisis | Day -14 to 24 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Diagnosis of systemic sclerosis according to ACR/EULAR 2013 classification (15).we include in the critera the fulfilling of 2013 EULAR/ACR criteria and specify disease duration (less than 2 years), score/clinical evidence for active disease :
Severe and resistant to low dose steroids and at least 2 immunosuppressive treatment including csDMARDs (methotrexate, azathioprine, mycophenolate mofetil) and at least one bDMARDs (Tocilizumab)
Early onset (less than 2 years).
Severity & progression of disease be defined by :
- .mRSS >15 with at least one organ involvement (lung: FVC <80%, renal involvement, cardiac involvement, Creatinine < 1.5 mg/dl within 6 months).
- mRSS <15 and lung fibrosis progression (FVC -10% DLCO -15% within 6 months)
patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab.
Estimated survival time > 24 weeks
Age: ≥18 ≤64 years old voluntary to participate in the study and sign the informed consent
Adequate organ functions assessed :
- serum Creatinine clearance > 40ml/mi
- adequate bone marrow function (Hemoglobin ≥9g/dL ; PMN ≥ 1 G/L ; Platelets ≥ 100 G/L)
- Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin < 2.0 mg/dL (34 μmol/L) (or < 3.0 mg/dL \[51 μmol/L\] for subjects with Gilbert's syndrome)
- Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation >/= 92% on room air
Highly effective contraception methods
Inclusion criteria:
Adequate organ functions assessed:
- serum Creatinine clearance > 40ml/mi
- adequate bone marrow function (Hemoglobin ≥9g/dL ; PMN ≥ 1 G/L ; Platelets ≥ 100 G/L)
- Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin < 2.0 mg/dL (34 μmol/L) (or < 3.0 mg/dL \[51 μmol/L\] for subjects with Gilbert's syndrome)
- Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation >/= 92% on room air
Adequate venous access for apheresis
Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)
Leucapheresis : at least 12 weeks after biotherapy (i.e. tocilizumab, 6 months for rituximab),
- Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
- ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%
- Lung and / or heart severe dysfunction defined by CVF<50% and/or DLCO <40%
- Pulmonary arterial hypertension defined by catheterism (mean AP > 25mmHg at rest or > 30mmHg after exercise, PAOP < 15mmHG)
- Clinically significant active, opportunistic, chronic or recurrent infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months including active or latent tuberculosis (TB) infection
- Contra indication for autologous hematopoietic stem cell transplantation (AHSCT ) or relapsing at least one year after AHSCT
- Active hematological or solid neoplasm
- Concurrent therapy with systemic steroids (>10 mg/d prednisone equivalent) within 2 weeks prior to inclusion, except inhaled steroids
- Methylprednisolone or prednisone (maximum dose 20 mg) instead of immunosuppressive agents
- T cell targeting drugs (e.g. mycophenolate mofetil, azathioprine, calcineurin inhibitors) within 6 weeks prior to leukapheresis
- Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy
- Live vaccines within 6 weeks prior to leukapheresis
- Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication/salvage therapies for treatment related toxicities
- patients without social security coverage;
- patients under guardianship;
- Male or female patients seeking to conceive a child
- Women of childbearing potential unless they are using a highly effective method of contraception starting from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells, and sexually active male participants unwilling to use a condom. Female partners of sexually active male participants must be on a highly effective form of birth control from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells.
- pregnant or breastfeeding women;
- patients with advanced cognitive disorders or any other cause preventing their informed consent;
- active, clinically significant CNS pathology : If signs or symptoms exist which present diagnostic uncertainty, neurologist consultation will be obtained to confirm the diagnosis of any neurological condition
- any comorbidity, whatever it may be, which may, in the opinion of the investigator, place the patient at additional risk or interfere with the monitoring of the study.
- Concurrent participation in any other interventional trial and Contraindication to the lymphodepleting chemotherapy
University Hospital, MontpellierStudy Central Contact
Contact: Charlotte KAAN, 04 67 33 48 53, [email protected]
4 Study Locations in 1 Countries
CHRU Lille, Lille, France
David LAUNAY, Pr, Contact, [email protected]
Ibrahim YAKOUB-AGHA, Pr, Sub-Investigator
Montpellier University Hospital, Montpellier, France
Charlotte KAAN, Contact
Christian JORGENSEN, Pr, Contact, 04 67 33 48 53, [email protected]
APHP Necker, Paris, France
Yannick ALLANORE, Pr, Contact, [email protected]
Olivier HERMINE, Pr, Sub-Investigator
Chu Rouen, Rouen, France
Olivier BOYER, PUPH, Contact, [email protected]