Study Evaluating Safety and Effectiveness of CD19 CAR-T Cell Therapy for Adults with Active Systemic Lupus Erythematosus

What this Trial Is About

Researchers are investigating the safety and effectiveness of CD19 CAR-T cell therapy for adults with active systemic lupus erythematosus SLE, a disease where current treatments often struggle to control symptoms or cause serious side effects. This study aims to address the need for better treatment options by exploring how this cell therapy works and how well patients tolerate it. It is a Phase 1 and Phase 2 clinical trial conducted by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants in the study will receive an intravenous infusion of CD19 CAR-T cells. After the infusion, patients will be followed for up to two years. The study involves monitoring various outcomes including safety, how the therapy moves and acts in the body, and changes in disease activity and immune markers. Regular assessments will take place at multiple time points during the follow-up period to track response and side effects. During the study, participants will have scheduled visits for clinical evaluations, blood tests, and questionnaires to measure disease activity and immune system changes. Researchers will look at safety and tolerability over two years, along with detailed lab tests such as antibody levels, complement proteins, and lupus severity indexes. This long-term follow-up helps understand the therapys effects and any risks, supporting comprehensive monitoring of participant health throughout the study.

A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus