Investigating CD19BCMA CAR-T Cell Therapy for Adults With Resistant Systemic Lupus Erythematosus

What this Trial Is About

Systemic lupus erythematosus SLE is an autoimmune disorder where the immune system attacks the bodys own tissues, causing inflammation and damage to multiple organs. This trial investigates a new treatment using CD19-BCMA CAR-T cells to target and eliminate the abnormal B cells responsible for producing harmful autoantibodies in patients with resistant SLE. The purpose is to find the highest dose of this therapy that patients can tolerate safely. Participants will receive chemotherapy drugs fludarabine phosphate and cyclophosphamide intravenously as preparation for the CAR-T cell infusion. On day 0, they will be given CD19BCMA-CAR T cells through an intravenous infusion lasting 10 to 20 minutes. Patients who respond well and tolerate the initial dose without serious side effects may receive 2 or 3 additional doses of the CAR-T cells. Throughout the study, participants will be closely monitored for any toxic side effects during the first 28 days after infusion. Researchers will assess how well the CAR-T cells are produced and expanded in the lab before infusion. Follow-up visits will continue to evaluate safety and treatment response, including blood tests, heart function checks, and other clinical assessments. The total study duration includes initial treatment and follow-up periods to track patient outcomes.

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)