NCT04959903

Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Smart Immune SAS · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic T cell progenitors, cultured ex-vivo	Injection of T cell progenitors at \[Day 4-Day 10\] after T cell depleted allogeneic HSCT

Timeline

• Start date: 2022-03-31
• Primary completion: 2025-08-01
• Completion: 2027-05-01
• First posted: 2021-07-13
• Last updated: 2023-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study