NCT06633328

CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

Clinical Study on the Safety and Efficacy of Donor Derived CD7 CAR-T Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the for Patients With Severe Aplastic Anemia

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia

Detailed description

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of CD7 CAR-T Bridging to allo-HSCT in the treatment of severe aplastic anemia.The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	CD7 CAR-T cells injection	CD7 CAR T cells treat patients with severe aplastic anemia
OTHER	Allogeneic hematopoietic stem cell transplantation	In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia

Timeline

• Start date: 2024-10-20
• Primary completion: 2027-10-20
• Completion: 2027-10-20
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: China