A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Non-Hodgkin lymphoma
All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
Age > 18 years old, ≤ 70 years old, male or female;
Diagnosis of relapsed/refractory (R/R) indolent B-cell lymphoma, and/or R/R diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as one of the following：
Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or another CD20 antibody drug and at least two treatment regiments appropriate for their disease, one of which should include anthracyclines;
Patients with present or history of central nervous system diseases not associated with leukemia or lymphoma， such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion;
Patients who participated in other clinical trials within 30 days prior to enrollment;
Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level > 1000 copies/ml) or hepatitis C (HCV RNA positive);
Sequential
Metabolically Armed CD19 CAR-T cells
DrugEach subject receive metabolically armed CD19 CAR- T cells by intravenous infusion.
MTD
Determine the Maximal Tolerable Dose(MTD).
Objective response rate (ORR)
Measure Tumor response rate (including CR and PR).
Concentration of CAR-T cells
Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion.
Pharmacodynamics of CAR-T cells
Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point.
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Zhejiang University
Lead sponsor
Leman Biotech Co., Ltd.
Collaborator
