Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
Xiaowen Tang
Suzhou, Jiangsu, China
RECRUITINGComplete Remission Rate
MRD Negative Remission Rate after CD19CD22 cell therapy
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Complete Remission Rate of VA regime
Complete Remission Rate after VA regime
Time frame: The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
Complete Molecular Remission Rate
Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Overall survival (OS)
From the first infusion of CD19CD22 cells to death or the last visit
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Leukemia-free survival (LFS)
Up to 2 years after CD19CD22 CAR-T cells infusion
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
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