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Recruiting Phase 1, Phase 2 NCT06503094

CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors

Trial Parameters

Condition B-Cell Lymphoblastic Leukemia/Lymphoma
Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 80
Sex ALL
Min Age 14 Years
Max Age 75 Years
Start Date 2024-01-14
Completion 2025-12-18
Interventions
CD19&CD20 bispecific CAR-T cells

Brief Summary

This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD20 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.

Eligibility Criteria

Inclusion Criteria: * Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment protocol, laboratory tests, and other study requirements specified in the flow sheet; * CD 19 + / CD 20 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor: 1. Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met): i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard chemotherapy regimen; iii. No complete remission or recurrence after first-line or multiline salvage chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or relapse after HSCT due to conditional limitations. 2. Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5): i . After four

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