NCT07120607

Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia

Clinical Study on the Safety and Efficacy of CD7 CAR-γδT Cell Injection for the Treatment of Relapsed/Refractory Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0/M1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk genetic abnormalities (such as TP53 mutations or complex karyotypes). CD7-positive AML patients typically have poor prognosis, poor response to standard chemotherapy, and shorter overall survival (OS). Targeted CD7 cell therapies may represent a promising direction for the treatment of these diseases.

Detailed description

This study is a single-arm,open-label, dose-escalation clinical trial. It is planned to enroll 9-18 patients with CD7-positive relapsed/refractory T-ALL/LBL and relapsed/refractory AML. The study will use a 3+3 design for dose escalation, with three initial dose groups: 1\*10\^8 CAR+ cells, 3\*10\^8 CAR+ cells, and 6\*10\^8 CAR+ cells.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD7 CAR-γδT cell（QH106）	Allogenic CD7 CAR-γδT cell，Intravenous on day0; dose escalation (3+3) : dose 1 (1 × 10\^8 CAR+ cells) , dose 2 (3 × 10\^8CAR+ cells/kg，dose 3 (6× 10\^8 CAR+ cells）;
DRUG	Fludarabine (FLU)	Intravenous fludarabine 30\~50 mg/m\^2/day on days-5, -4, and -3；
DRUG	Cyclophosphamide (CTX)	Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.

Timeline

• Start date: 2025-08-18
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-08-13
• Last updated: 2025-08-13