Trials / Recruiting
RecruitingNCT05768035
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Smart Immune SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-06
- Primary completion
- 2025-07-01
- Completion
- 2026-07-01
- First posted
- 2023-03-14
- Last updated
- 2023-09-25
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05768035. Inclusion in this directory is not an endorsement.