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
Smart Immune SAS
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Group A (adults): 1. Adult patients affected by: * Acute leukemia (AML, ALL) defined as: * Acute Myeloid Leukemia (AML): * High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities * Chemo-refractory relapse (MRD+) * ≥ CR2 * Acute Lymphoblastic Leukemia (ALL): * Chemo-refractory relapse (MRD+) * High risk ALL in CR1; Philadelphia (like) or any poor risk feature * ≥ CR2 * Acute leukemia of ambiguous lineage: * ≥ CR1 with a minimal…
Interventions
- BiologicalAllogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors at \[Day 4-Day 10\] after T cell depleted allogeneic HSCT
Location
- Memorial Sloan Kettering Cancer Center (MSKCC)New York, New York