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

Inclusion Criteria

• •1\. Age ≥18 years old, gender unlimited;
• •2\. Abnormal B cell immunotyping was CD19 positive;
• •3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
• •4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:
• •1. No CR was obtained after standard chemotherapy;
• •2. CR was induced for the first time, but the duration of CR was less than 12 months;
• •3. R/R B-ALL that does not work after the first or more remedial treatments;
• •4. Two or more relapses;
• •5\. 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;
• •6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
• •7\. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
• •8\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
• •9\. The estimated survival is more than 3 months;
• •10\. ECOG score 0-2;
• •11\. 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);
• •12\. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent.