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A Phase I/II Study Evaluating the Safety and the Efficacy of SMART101 Injection to Accelerate Immune Reconstitution After T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric and Adult Patients With Hematological Malignancies
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.
Details
| Lead sponsor | Smart Immune SAS |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 36 |
| Start date | 2022-03-31 |
| Completion | 2027-05 |
Conditions
- Hematological Malignancies
Interventions
- Allogeneic T cell progenitors, cultured ex-vivo
Primary outcomes
- Cumulative incidence of grade III-IV GvHD — 100 days post-HSCT
to evaluate the safety profile of the study drug - Occurrence of adverse events related to SMART101 — 100 days post-HSCT
Number of adverse events and serious adverse events related to SMART101 tabulated for each dose and by age group to evaluate the safety profile of the study drug - CD4+ T cell count — 100 days post-HSCT
to evaluate the efficacy of the study drug
Countries
United States