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Clinical Trial NCT05768035 for Hematological Malignancies is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide Phase 1, Phase 2 40

Recruiting
Clinical Trial NCT05768035 is designed to study Treatment for Hematological Malignancies. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 6 June 2023, with plans to enroll 40 participants. Led by Smart Immune SAS, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 25 September 2023.
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.
Official Title

An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

Conditions
Hematological Malignancies
Other Study IDs
  • SI101-02
NCT ID Number
NCT05768035
Start Date (Actual)
2023-06-06
Last Update Posted
2023-09-25
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
AML, ALL, MSD
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPatients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT
Segment 1: 3 dose-level SMART101 cells/infusion 1. 1.5 x 106 CD7+ cells per kg of body weight 2. 4.5 x 106 CD7+ cells per kg of body weight 3. 9.0 x 106 CD7+ cells per kg of body weight Segment 2: 2 cohorts of patients will be included in the study based on the type of conditioning regimen: * The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC). * The cohort B will include up t...Show More
Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.
To evaluate the safety of SMART101.
14 days post SMART101 infusion
CD4+ T cell count.
to evaluate the efficacy of the study drug
100 days post-HSCT
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Occurrence of adverse events (AEs)
up to 24 months post-HSCT
T cell immune reconstitution
Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells
up to 12 months post-HSCT
Cumulative incidence of infections
Day 100, and Months 6 and 12 post-HSCT
Non-relapse mortality (NRM)
Day 100, and Months 6, 12 and 24 post-HSCT
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.
  • Patients must be ≥ 18 years of age at the time of signing the ICF.
  • Patients must have a Karnofsky index ≥ 70%.
  • Patients must have a left ventricular ejection fraction of ≥40%.
  • Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.
  • Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.

  • Patients who have received prior allogeneic stem cell transplantation.
  • Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.
  • Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.
Smart Immune SAS logoSmart Immune SAS
Study Central Contact
Contact: Frédéric LEHMANN, MD, +32 (0) 492 46 23 55, [email protected]
Contact: Aurélie BAUQUET, PhD, [email protected]
4 Study Locations in 1 Countries
Institut Paoli Calmettes, Marseille, 13009, France
Raynier Devillier, Pr, Principal Investigator
Recruiting
Centre hospitalier universitaire de Nantes, Nantes, 44093, France
Patrice Chevallier, MD, PhD, Principal Investigator
Recruiting
Hôpital Saint-Louis, Paris, 75010, France
Régis Peffault de Latour, Pr, Principal Investigator
Recruiting
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole, Toulouse, 31059, France
Anne Huynh, MD, Principal Investigator
Recruiting