IM19CAR-T(Beijing Immunochina Pharmaceuticals)

The study is a single-arm, open-label clinical trial intended to recruit 3 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10^6/kg CAR-T cells. The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the study aims to assess long-term efficacy, specifically achieving the treatment endpoint of lupus low disease activity state (LLDAS) at 360 days post-infusion, and long-term improvement in disease activity as measured by SLEDAI-2K at 360 days. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.