This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Occurrence of treatment related adverse events
Assessed by CTCAE v4.0
Time frame: Day 1-100 days after injection
Objective response rate
Objective response include complete remission and partial remission
Time frame: Day 1-5 years after injection
Overall survival
Time frame: Day 1-5 years after injection
Progression free survival
Time frame: Day 1-5 years after injection
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