CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.
Liang Wang
Beijing, Beijing Municipality, China
RECRUITINGBest ORR
Overall response rate means sum of complete response rate and partial response rate
Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Best CR rate
CR was defined as complete remission evaluated using PET-CT scan or BM test
Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Progression free survival (PFS)
PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason
Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
overall survival (OS)
OS was defined from the date of CAR-T infusion to the date fo death
Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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