CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors
NCT Number: NCT06503094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: B-Cell Lymphoblastic Leukemia/Lymphoma
Interventions: DRUG: CD19&CD20 bispecific CAR-T cells
Sponsor: Wuhan Union Hospital, China
Collaborators: Hebei Taihe Chunyu Biotechnology Co., LTD|Zhujiang Hospital|Jingzhou Central Hospital|Shiyan People's Hospital|Xiangyang Central Hospital|Yichang Central People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-14
Completion Date: 2026-06-18
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China

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.

Primary Outcome Measures: Overall response rate (ORR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors, Disease overall response rate (ORR) will be assessed from CAR-T cell infusion to death or last follow-up (censored)., within 3 years after infusion|Incidence of Treatment-related Adverse Events, Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)., within 3 years after infusion|Complete response rate (CR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors, CR will be assessed from CAR-T cell infusion to death or last follow-up (censored)., within 3 years after infusion|Partial response rate (PR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors, PR will be assessed from CAR-T cell infusion to death or last follow-up., within 3 year after infusion
Secondary Outcome Measures: Overall survival (OS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors, OS will be assessed from CAR-T cell infusion to death or last follow-up (censored)., within 3 years after infusion|Progress-free survival (PFS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors, PFS will be assessed from CAR-T cell infusion to death or last follow-up (censored)., within 3 years after infusion|Event-free survival (EFS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors, EFS will be assessed from CAR-T cell infusion to death or last follow-up (censored)., within 3 years after infusion
Other Outcome Measures: In vivo expansion and survival of CD19&CD20 dual-target CAR-T cell therapy in relapsed/refractory B-cell hematological malignancies, Quantity of CAR-T-CD19 CAR copies in bone marrow, peripheral blood and cerebrospinal fluid will be determined by using flow cytometry and quantitative polymerase chain reaction., within 3 years after infusion