Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT
NCT04959903 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-03-06
Summary
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.
Conditions
Interventions
- BIOLOGICAL
-
Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors at \[Day 4-Day 10\] after T cell depleted allogeneic HSCT
Sponsors & Collaborators
-
Smart Immune SAS
lead INDUSTRY
Principal Investigators
-
Jaap-Jan BOELENS, MD, PhD · Memorial Sloan Kettering Cancer Center (MSKCC)
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2025-08-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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