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.
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;
B-cell acute lymphoblastic leukemia (B-ALL);
Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
Invasive B-cell lymphoma (DLBCL, BL, and MCL);
Appearance of one of the following cardiac criteria: atrial fibrillation; myocardial infarction in the last 12 months; prolonged QT syndrome or secondary QT extension, as judged by the investigator. Echocardiography LVSF <30% or LVEF <50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (confirmed by echocardiography within 12 months of treatment).
Active GVHD.
History of severe pulmonary function impairment disease.
Other malignant tumors in the advanced stage.
Single group
CD19&CD20 bispecific CAR-T cells
DrugEach patient will receive CD19\&CD20 bispecificCAR-T cells by intravenous infusion on day 0.
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).
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).
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).
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.
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).
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).
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).
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.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
Zhujiang Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
Shiyan People's Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
