Safety and Effectiveness Study of Umbilical Cord Blood-Derived CAR-T Cell Therapy for Adults with Refractory Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating an allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell UCAR-T therapy targeting CD19 and BCMA to treat adults with refractory systemic lupus erythematosus SLE. This early phase 1 trial aims to understand the safety and effectiveness of this UCAR-T cell product, focusing on its impact on disease activity and remission outcomes in adults with difficult-to-treat SLE. Participants may receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide if clinically needed before receiving a UCAR-T cell infusion delivered intravenously on Day 0. After infusion, participants will stay hospitalized for at least 7 days for close monitoring and remain within two hours of the treatment center for 28 days. Follow-up visits are scheduled at Day 14, Day 28, and at months 3, 6, 9, 12, 18, and 24 post-infusion to assess safety and treatment effects. During the study, researchers will monitor adverse events for up to two months after infusion and track dose-limiting toxicities within 28 days. They will also evaluate changes in disease activity scores, remission rates, and maintenance of drug-free remission over two years. Participants will undergo regular clinical assessments and safety monitoring throughout the study period, which can last up to two years after treatment.

Allogeneic UCB-derived CAR-T for SLE