A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

Inclusion Criteria23

• Male or female aged 3-70 years;
• Histologically confirmed diagnosis of 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 followingconditions):
• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration isless than 12 months;
• Ineffectively after first or multiple remedial treatments;
• or more relapses;
• The number of primordial cells (lymphoblast and prolymphocyte)in bone marrow is\>5% (by morphology), and/or \>1% (by flowcytometry);
• Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• Male or female aged 18-75 years;
• Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHOClassification Criteria for Lymphoma (2016);
• Relapsed or refractory B-NHL (meeting one of the followingconditions):
• No response or relapse after second-line or abovechemotherapy regimens;
• Primary drug resistance;
• Relapse after auto-HSCT;
• At least one assessable tumor lesion per Lugano 2014 criteria;
• Highly suspected or confirmed central nervous system involvement of hematological malignancies;
• 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 ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.