BMS-986553

BMS-986553 (formerly OTX-201) is an investigational in vivo CD19-targeted chimeric antigen receptor (CAR) T-cell therapy being developed by Bristol Myers Squibb (following its acquisition of Orbital Therapeutics in 2025) for the treatment of refractory B-cell-driven autoimmune diseases. The therapy consists of an optimized circular RNA (circRNA) encoding an anti-CD19 CAR, encapsulated within targeted lipid nanoparticles (LNPs). Upon intravenous administration, the LNPs deliver the circRNA directly to the patient's T cells in vivo, reprogramming them to express the CD19 CAR and transiently deplete autoreactive B cells. This approach aims to reset the immune system while avoiding the complex manufacturing, high costs, and intensive conditioning regimens associated with traditional ex vivo CAR-T cell therapies. BMS-986553 is currently in Phase 1 clinical development for refractory autoimmune diseases, including systemic lupus erythematosus, idiopathic inflammatory myopathies, systemic sclerosis, rheumatoid arthritis, Sjögren's disease, and lupus nephritis.

Other names

CD19 in vivo CAR T cellsCD-19 in vivo CAR T cellsCD 19 in vivo CAR T cellsCD19 in vivo Chimeric Antigen Receptor T cellsCD-19 in vivo Chimeric Antigen Receptor T cellsCD 19 in vivo Chimeric Antigen Receptor T cells