Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia
NCT07120607 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-08-13
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Anhui Provincial Hospital
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-18
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
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