Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
NCT05768035 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-09-25
Summary
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.
Conditions
Interventions
- BIOLOGICAL
-
Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide
Sponsors & Collaborators
-
Smart Immune SAS
lead INDUSTRY
Principal Investigators
-
Fabio CICERI, MD, Pr. · I.R.C.C.S. Ospedale San Raffaele
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-06
- Primary Completion
- 2025-07-31
- Completion
- 2026-07-31
Countries
- France
Study Locations
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