Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

Inclusion Criteria16

• \. Age ≥18 years old, gender unlimited;
• \. Abnormal B cell immunotyping was CD19 positive;
• \. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
• \. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:
• No CR was obtained after standard chemotherapy;
• CR was induced for the first time, but the duration of CR was less than 12 months;
• R/R B-ALL that does not work after the first or more remedial treatments;
• Two or more relapses;
• \. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria;
• \. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
• \. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
• \. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
• \. The estimated survival is more than 3 months;
• \. ECOG score 0-2;
• \. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks);
• \. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent.