NCT06880354

A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.

Detailed description

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects. The main purpose of this study is to evaluate the safety of CLL1 and CD38 dual - target CAR - T cell injection in the treatment of r/r AML and the study contains two phases with the first phase adopting an ATD design and the second phase adopting a 3+3 design.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CLL1 and CD38 Dual-Target CAR-T Cell Injection	This product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that targets both CLL1 and CD38.

Timeline

• Start date: 2025-05-22
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-03-17
• Last updated: 2025-06-03

Locations

1 site across 1 country: China