This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
Patients who are diagnosed with relapsed/refractory B cell non-Hodgkin lymphoma , especially
Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),
Primary Mediastinal Large B Cell Lymphoma (PMBCL)
Transformation Follicular Lymphoma (TFL)
Individuals who have antiCD45 or antiCD3 therapy
Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases
Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
History of allogeneic stem cell transplantation
Single group
CD19/CD20/BCMA CAR T cells
Biological/VaccineSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells. Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection
Dose-limiting toxicity(DLT)
Safety
Maximum tolerated dose (MTD)
Tolerability
Maximum Plasma Concentration(Cmax)
Pharmacokinetics (PK)
Maximum Plasma Concentration Time (Tmax)
Pharmacokinetics (PK)
Area Under Curve (AUC)
Pharmacokinetics(PK)
CAR positive T cells
Pharmacokinetics(PK)
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