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 (HTLP-ONCO)
NCT04707300 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-11-20
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.
Conditions
- Hematologic Malignancy
Interventions
- DRUG
-
Human T Lymphoid Progenitor (HTLP) injection
The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Olivier HERMINE, PhD & MD · Assistance Publique - Hôpitaux de Paris
-
Elisa MAGRIN, MD · Département de Biothérapie : Hôpital Necker Enfants malades
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 66 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-16
- Primary Completion
- 2026-11-30
- Completion
- 2028-08-31
Countries
- France
Study Locations
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