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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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);
Intravenous fludarabine 30\~50 mg/m\^2/day on days-5, -4, and -3;
Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.
Incidence of Adverse Events (AEs)
AE is defined as any adverse medical event from the date of lymphocyte depletion chemotherapy to 12 months after QH106 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versus-host disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Time frame: 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of QH106 up to 28 days
Pharmacodynamics: Peak level of cytokines in serum
Time frame: Up to 28 days after infusion
Pharmacokinetics: Persistence of QH106
Persistence of QH106 assessed by number in peripheral blood
Time frame: 12 months
Overall Response rate (ORR)
CR (complete remission) /CRh (CR with partial hematological recovery) The proportion of subjects who achieved remission /CRi (complete remission with incomplete hematological recovery) /PR (partial remission)
Time frame: 12 months
Negative remission rate of minimal residual disease (MRD) in leukemia
Time frame: 12 month
Duration of remission (DOR)
Time frame: 12 month
Leukemia-free survival period(LFS)
Time frame: 12 month
Overall survival (OS)
Time frame: 12 month
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)
Time frame: 12 month
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