Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia

Sponsor
Anhui Provincial Hospital
Study ID
NCT07120607
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD7 CAR-γδT cell（QH106） — BIOLOGICAL
    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）;
  • Fludarabine (FLU) — DRUG
    Intravenous fludarabine 30\~50 mg/m\^2/day on days-5, -4, and -3；
  • Cyclophosphamide (CTX) — DRUG
    Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.

Study Details

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.

Key Dates

First listed
Aug 13, 2025
Start date
Aug 18, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: 12 months ]

Central Contacts

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