A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
• 1\. Gender unlimited,18\< Age;
• 2\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma
• 3\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
‣ CR not achieved after standardized chemotherapy;
⁃ CR achieved following the first induction, but CR duration is less than 12 months;
⁃ Ineffectively after first or multiple remedial treatments;
⁃ 2 or more relapses;
• 4\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
• 5\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• 6\. Relapsed or refractory B-NHL (meeting one of the following conditions):
‣ No response or relapse after second-line or above chemotherapy regimens;
⁃ Primary drug resistance;
⁃ Relapse after auto-HSCT;
• 7\. At least one assessable tumor lesion per Lugano 2014 criteria;
• 8\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• 9\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• 10\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• 11\. Estimated survival time ≥ 3 months;
• 12\. ECOG performance status 0 to 2;
• 13\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.