This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 24 months
Overall remission rate (ORR)
Time frame: 3 months
Response at Day 28 days
Time frame: 1 month
Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.
Time frame: 6 months
Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow
Time frame: 6 months
Relapse-free survival (RFS)
Time frame: 24 months
Duration of remission (DOR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
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