Non Hodgkin Lymphoma Clinical Trial
Official title:
Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) Formulation for the Treatment of Relapsed/Refractory CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL)
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very small infusion dose to improve safety. In this study, a "3+3" design was adopted, and four dose groups were set up with 1×105/kg, 3×105/kg, 5×105/kg, and 10×105/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 1×108 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells. ;
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