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 \& CD22 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
HGB≥70g/L(transfusible)
Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
Cardiopulmonary function: left ventricular ejection fraction >50%; Blood oxygen saturation >90%;
Serious heart insufficiency,LVEF <50%
History of severe pulmonary function impairment disease.
Other malignant tumors in the advanced stage.
Severe infection or persistent infection that cannot be effectively controlled.
Single group
CD19&CD22 bispecific CAR-T cells
DrugEach patient will receive CD19\&CD22 bispecific CAR-T cells by intravenous infusion on day 0
Overall response rate (ORR) of administering CD19&CD22 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).
Complete response rate (CR) of administering CD19&CD22 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).
Complete response with incomplete blood recovery rate (CRi) of administering CD19&CD22 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors
CRi will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Partial response rate (PR) of administering CD19&CD22 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.
Duration of Response (DOS) of administering CD19&CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors
DOS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Progress-free survival (PFS) of administering CD19&CD22 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).
Overall survival (OS) of administering CD19&CD22 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).
The Peripheral blood vector copy number of patients of CD19&CD22 dual-target CAR-T cell therapy in relapsed/refractory B-cell hematological malignancies
Quantity of CD19\&CD22 CAR copies in peripheral blood 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
