Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
• Inclusion criteria only for B-ALL:
‣ Male or female aged 3-70 years;
⁃ Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
⁃ 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;
⁃ The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
⁃ Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• Inclusion criteria only for B-NHL:
‣ Male or female aged 18-75 years;
⁃ Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
⁃ 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;
⁃ At least one assessable tumor lesion per Lugano 2014 criteria;
• Common inclusion criteria for B-ALL and B-NHL:
‣ Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
⁃ Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
⁃ No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
⁃ Estimated survival time ≥ 3 months;
⁃ ECOG performance status 0 to 2;
⁃ Patients or their legal guardians volunteer to participate in the study and sign the informed consent.