Early Phase Study of GC012F Dual Target CAR-T Cell Therapy for Adults with Treatment-Resistant Systemic Lupus Erythematosus

What this Trial Is About

Researchers are studying the use of GC012F injection, which contains CD19-BCMA CAR-T cells, in patients with refractory systemic lupus erythematosus SLE, an autoimmune disease involving multiple organs and caused by abnormal immune activity. This early exploratory phase study aims to find the maximum dose of this treatment that patients can tolerate, focusing on rebuilding normal immune function and potentially achieving drug-free remission. Participants will receive the GC012F injection by intravenous infusion on Day 0 during a dose escalation phase that tests increasing doses from 0.5 x 105kg up to 3 x 105kg. This single-arm, open-label trial does not randomize participants and monitors safety and response carefully. The study evaluates the treatments effects on immune cells and gene copies in blood and bone marrow over several weeks after infusion. During the study, participants will undergo regular evaluations including safety monitoring for adverse events within 12 weeks of treatment, assessments of disease activity and response using standardized criteria at multiple time points up to 24 weeks, and blood and bone marrow tests to measure CAR-T cell presence. Follow-up visits are required to track immune system rebuilding and overall health for up to 24 weeks post-infusion, with total participation spanning several months.

Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients