Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
• Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
• Relapsed or refractory B cell hematological malignancies (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;
⁃ Relapse after hematopoietic stem cell transplantation;
⁃ Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• Estimated survival time ≥ 12 weeks;
• ECOG performance status 0 to 2;
• Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.
• Patients volunteer to participate in the study and sign the informed consent.