Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
brief summary
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
detailed description
Based on the specific CD19-targeting CAR-T developed by 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 contain a high proportion of T naive cells, which can play a therapeutic role at a very low infusion dose and improve safety.
In this study, three dose groups were composed of 0.3×10\^5/kg, 1×10\^5/kg and 3×10\^5/kg CAR-positive cells, respectively.All subjects received only one infusion of MC-1-50 cells.
official title
Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)