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

NCT05768035 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Smart Immune SAS
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	40
Start date	2023-06-06
Completion	2026-07

Conditions

• Hematological Malignancies

Interventions

• Allogeneic T cell progenitors, cultured ex-vivo

Primary outcomes

• Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101. — 14 days post SMART101 infusion
  To evaluate the safety of SMART101.
• CD4+ T cell count. — 100 days post-HSCT
  to evaluate the efficacy of the study drug

Countries

France