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.
Since 2010, CAR-T ( chimeric antigen receptor T cell) therapy has shown good results in tumor treatment and has achieved positive clinical therapeutic effects in hematological tumors. The structure of the dual-target CAR-T of CD19 \& CD22 is designed with a 4-1BB costimulatory domain and an antigenic recognition region with a tandem structural sequence to recognize CD22 or CD19 by a single structure. CD19 \& CD22 bispecific CAR-T cells can identify CD 19 or CD 22 with the advantage that the single target CAR-T does not have, reducing the possibility of target loss. The structure has been optimized to enhance the safety to treat B cell-derived hematological tumors (at least CD19 positive or CD22 positive).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Each patient will receive CD19\&CD22 bispecific CAR-T cells by intravenous infusion on day 0
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGOverall 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).
Time frame: within 3 years after infusion
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).
Time frame: within 3 years after infusion
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).
Time frame: within 3 years after infusion
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.
Time frame: within 3 years after infusion
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).
Time frame: within 3 years after infusion
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).
Time frame: within 3 years after infusion
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).
Time frame: within 3 years after infusion
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.
Time frame: within 3 years after infusion
The Cmax of CAR T cells of CD19&CD22 dual-target CAR-T cell therapy in relapsed/refractory B-cell hematological malignancies
The highest concentration of CAR T cells amplified in peripheral blood (Cmax) during the treatment of relapsed/refractory B-cell hematological malignancies
Time frame: within 3 years after infusion
The Tmax of CAR T cells of CD19&CD22 dual-target CAR-T cell therapy in relapsed/refractory B-cell hematological malignancies
Time to maximum concentration of CAR T cells in peripheral blood (Tmax) during the treatment of relapsed/refractory B-cell hematological malignancies
Time frame: within 3 years after infusion
The AUC28D of CAR T cells of CD19&CD22 dual-target CAR-T cell therapy in relapsed/refractory B-cell hematological malignancies
Area under the curve of peripheral blood CAR T cells at 28 days in peripheral blood (AUC28D) during the treatment of relapsed/refractory B-cell hematological malignancies
Time frame: within 3 years after infusion
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