A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma
The patient or his/her guardian voluntarily signed the informed consent
Adult Patients clinical diagnosis of relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included)
A chemotherapy regimen containing anthracyclines
For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL.
Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Patients with history of allogeneic hematopoietic stem cell transplantation
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
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
Click on the lead sponsor to view all of their trials.
