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Recruiting EARLY_Phase 1 NCT06696833

Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Trial Parameters

Condition B-Cell Acute Lymphoblastic Leukemia, Adult
Sponsor The First Affiliated Hospital of Soochow University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 18
Sex ALL
Min Age 14 Years
Max Age N/A
Start Date 2024-12-01
Completion 2025-12-01
Interventions
QH10304-BAL-01FludarabineCyclophosphamide

Brief Summary

This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed/refractory B-ALL

Eligibility Criteria

Inclusion Criteria: 1. Age ≥14 years, gender not specified; 2. Diagnosed with B-ALL according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version); 3. Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory B-ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells \>5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy;those with positive measurable residual disease can also be included; 4. Flow cytometry confirms positive CD19 expression in leukemia cells; 5. Estimated survival \>3 months; 6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 7. The vital organs function in accordance with the following requirements: 7.1Left ventricular ejection

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