Phase 1 Study of BMS-986515 Healthy Donor CD19-targeted CAR T Cell Therapy for Adults with Severe Treatment-Resistant Autoimmune Diseases

What this Trial Is About

Researchers are studying BMS-986515, a healthy donor allogeneic CD19-targeted CAR T cell therapy, to assess its safety, tolerability, best dosing, and early effectiveness in adults with severe, treatment-resistant autoimmune diseases. This phase 1 trial focuses on participants with refractory autoimmune conditions such as systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis who have not responded adequately to standard treatments. Participants receive BMS-986515 along with drugs including fludarabine, cyclophosphamide, and tocilizumab in specified doses given on set days. The study is designed as a single group intervention evaluating the investigational cellular therapys impact and safety profile over time, with close monitoring following the infusion of the CAR T cells. During the trial, participants will undergo extensive safety and response assessments up to 24 months after receiving BMS-986515. Researchers will track adverse events, laboratory results, and signs of disease remission or activity using specific clinical criteria and questionnaires. The study includes long-term follow-up to evaluate ongoing effects and tolerability of the treatment.

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases