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Clinical Trial NCT04707300 (HTLP-ONCO) for Hematologic Malignancy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Assistance Publique - Hôpitaux de ParisStudy Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO) Phase 1, Phase 2 10 Open-Label
Clinical Trial NCT04707300 (HTLP-ONCO) is designed to study Treatment for Hematologic Malignancy. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 16 February 2022, with plans to enroll 10 participants. Led by Assistance Publique - Hôpitaux de Paris, it is expected to complete by 1 August 2028. The latest data from ClinicalTrials.gov was last updated on 20 November 2025.
Brief Summary
This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.
Detailed Description
Allogeneic bone marrow transplantation (AlloSCT) is the treatment of choice for high- risk acute myeloid leukemias in complete first remission after induction therapy and other high-risk hematological malignancies. Umbilical cord blood grafts are frequently used for patients lacking an HLA- matched family donor (Matched-sibling donor, MSD) as well as in the absence of an appropriate unrelated donor (10/10 MUD). As an...Show More
Official Title
A Phase I/II Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies
Conditions
Hematologic MalignancyOther Study IDs
- HTLP-ONCO
- APHP191116
- 2019-004883-23 (EudraCT Number)
NCT ID Number
Start Date (Actual)
2022-02-16
Last Update Posted
2025-11-20
Completion Date (Estimated)
2028-08
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
acute myeloid leukemia
minimal residual disease
hematologic malignancies
human T Lymphoid Progenitor
umbilical cord blood transplantation
minimal residual disease
hematologic malignancies
human T Lymphoid Progenitor
umbilical cord blood transplantation
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHuman T Lymphoid Progenitor (HTLP) injection HTLP cellular product obtained after 7 days of culture of immune-selected CB | Human T Lymphoid Progenitor (HTLP) injection The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative incidence of grade III-IV graft-versus-host disease (GvHD) | according to Glucksberg grading system, to define toxicity | Within 100 Days following HSCT |
CD4 + T cells analysis | Efficacy defined by the presence of \>50/μl CD4+ CD3+ TCRαβ+ T cells at 2 consecutive measures \< within 4 months post HSCT. | Within 100 days following HSCT |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to hematologic engraftment | ANC \> 0.5G/L and platelets \> 20G/L on 3 consecutive days | Up to 24 months post-transplantation |
Last transfusion of platelets and red blood cell | During the follow-up | |
Absolute numbers of neutrophils | Month 1, 2, 3, 6 and 12 post -transplantation | |
Time course of T cell immune reconstitution | by immunophenotyping (flow cytometry analysis) - with a focus on time needed to exceed a count of 100 naive CD4+ and \>100 total CD8+ cells per μL | Month 1, 2, 3, 6 and 12 post -transplantation |
Immune phenotype (flow-cytometry analysis) of the different TCRαβ+ cell subpopulations | TCD4 naive/memory population (CD31+CD45RA+/CD4+, CD45RO/CD4+; CD31+CD4+); TCD8 naive/memory population (CD45RA+CCR7+/CD8+, CD45RA-CCR7+/ CD8+, CD45RA- CCR7+/ CD8+, CD45RA-CCR7-/CD8+) , CD8 effector memory RA+ (TEMRA) (CD45RA+CCR7- /CD8+ ); Regulatory T cells (CD4+CD25+CD127lowCD25+).
• Analysis of CD3, CD4, CD8 numbers will be performed if total lymphocytes ≥ 500/μL and analysis of T cell subpopulations if CD3+ cells ≥ 1000/μL | Month 1, 2, 3, 6 and 12 post -transplantation |
B-cell reconstitution | (B CD19 naive/memory population (CD27-IgD+/CD19+, CD27+IgD+/CD19+, CD27+IgD-/CD19 and Ig levels) at 1, 2, 3, 6 and 12 months post HSCT with focus on time needed for cessation of intravenously IgG replacement therapy | Month 1, 2, 3, 6 and 12 post -transplantation |
Reconstitution of the NK cell | compartment (CD16+CD56+) | Month 1, 2, 3, 6 and 12 post -transplantation |
Assessment of engraftment of each UCB unit over time by hematological monitoring and chimerism analysis | at 1, 2, 3, 6 and 12 months following HSCT and between M1 and M2 post-transplantation if necessary according to the result of the chimerism at M1 on neutrophils, T, B, NK, pDC and macrophages.
• The chimerism is studied on whole blood and on mononuclear cells (i.e. cells reconditioning after Ficoll) until the total number of lymphocyte is ≥ 100/μL.
When lymphocyte count is ≥ 100/μL, the chimerism will be analysed on immunoselected cell populations (CD15+/CD3+/NK, CD19+) | at 1, 2, 3, 6 and 12 months following HSCT. |
Graft failure/rejection rate | detected by hematological monitoring of each UCB unit | at 3 months following HSCT |
Cumulative incidence of infections | at 3, 6 and 12 months post- transplantation | |
Cumulative incidence of acute and chronic episodes of GVHD and their grade according to Glucksberg GvHD staging. | at 3, 6, 12 and 24 months post-transplantation | |
Relapse rate | 2 years | |
Overall survival | 2 years | |
Disease-free survival | 2 years | |
Progression-free survival | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adult patients (≥ 18 years old and <66 years old) at the time of inclusion and eligible for an allogeneic stem cells transplantation and fit to receive the specified conditioning regimen
- Patients with hematologic malignancies
- Absence of a matched - related sibling donor (MSD) or a matched unrelated donor (MUD) 10/10
- Presence of two UCB units with the following criteria*: HLA- matched 4/8, 5/8, 6/8, 7/8 or 8/8 for HLA- A, -B, -C and DRB1 loci
AND
• Presence of at least one UCB unit with the following criteria*: ≥ 3 x 10e7 TNC/kg or ≥ 1.5 10e5 CD34+/kg pre- freezing
* For the UCB taken into HTLP culture, the CD34+ content does not need to meet the above cellularity criteria, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7+ needed for each dose.
The non- cultured UCB will be chosen to have a higher CD34+ cell content in order to enable long- term hematopoietic engraftment
- Absence of Donor Specific Antibodies (DSA) with a MFI > 5000
- Patient affiliated to social security
- Written, informed consent of the patient
- Any of the standard contraindications to allogeneic transplant
- Left ventricular ejection fraction <50%
- Abnormal biochemistry results (ALT/AST>10xULN, total bilirubin>2.5xULN, creatinin clearance <60ml/min)
- Inability to understand and provide informed consent
- Concomitant infectious disease: HTLV-I, HIV-I or HIV-II
- Pregnancy or breastfeeding for women of childbearing potential
- Patients with progressive hematologic malignancies
- Previous participation within one month before inclusion in another protocol in which drugs may influence immune reconstitution of bone marrow transplantation
Assistance Publique - Hôpitaux de Paris967 active studies to exploreURC-CIC Paris Descartes Necker CochinStudy Central Contact
Contact: Olivier HERMINE, PhD & MD, +33 144495282, [email protected]
Contact: Nelly Briand, PhD, 01 44 38 18 62, [email protected]
5 Study Locations in 1 Countries
Hôpital Saint Louis, Paris, France
Nicolas BOISSEL, MD, PhD, Contact, +33 1 42 49 96 43, [email protected]
Recruiting
Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux, Pessac, 33604, France
Edouard FORCADE, PhD & MD, Contact, [email protected]
Recruiting
IUCT Oncopole Toulouse, Toulouse, France
Anne HUYNH, PhD, MD, Contact, 05 31 15 71 91, [email protected]
Recruiting
Institut Gustave Roussy, Villejuif, France
Jean-Henri BOURHIS, PhD MD, Contact, +33 1 42 11 53 82, [email protected]
Not yet recruiting
Île-de-France Region
Hematology department / Necker Children's Hospital, Paris, Île-de-France Region, 75015, France
Olivier HERMINE, PhD & MD, Contact, +33 144495282, [email protected]
Felipe SUAREZ, PhD & MD, Contact, [email protected]
Recruiting