Study of CD19 Universal CAR-b3b4T Cell Treatment for Adults With Active Systemic Lupus Erythematosus

What this Trial Is About

Researchers are studying CD19 Universal CAR-b3b4T cells as a potential treatment for adults with active severe systemic lupus erythematosus SLE, a condition where current therapies often fail to fully control disease activity. This study aims to assess the safety, tolerability, early effectiveness, and how the body processes and responds to these CAR-T cells. The trial is led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive an intravenous infusion of CD19 Universal CAR-b3b4 T Cells. The study includes a treatment phase where the cells are given, followed by a long-term follow-up period lasting up to two years. During this time, researchers will monitor various health and disease activity markers to understand the treatments effects. Throughout the study, participants will have regular visits for assessments including safety checks, disease activity scores SELENA-SLEDAI and Physician Global Assessment, immunological tests, and levels of specific antibodies in the blood. Researchers will track these outcomes at multiple time points up to 24 months after infusion. This follow-up ensures close monitoring of participant health and how the therapy interacts with their condition over time.

A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus