Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
brief summary
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 Acute Lymphoblastic Leukemia.
detailed description
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 low infusion dose to improve safety. In this study, a \"3+3\" design was adopted, and three dose groups were set up with 1×10\^5/kg, 3×10\^5/kg, and 5×10\^5/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 5×10\^7 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.
official title
Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Relapsed/Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL)