NCT07126782

The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT

Clinical Study on the Efficacy and Safety of Allogeneic γδ T Cells in the Treatment of Patients With MRD-positive Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT.

Detailed description

This is a single-center, randomized, open label phase I clinical trial to evaluate the efficacy and safety of ex-vivo expanded allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT. The infusion doses of γδ T cells were 2E8 cells/kg and 4E8 cells/kg.

Conditions

• AML (Acute Myelogenous Leukemia)
• AML

Interventions

Type	Name	Description
BIOLOGICAL	Ex-vivo expanded allogeneic γδ T cells	Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδ T cells from donors will be adoptively transfused.

Timeline

• Start date: 2025-07-20
• Primary completion: 2027-12-20
• Completion: 2028-07-20
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: China