Novartis and Bristol Myers pause multiple autoimmune CAR-T trials after serious immune adverse events

Novartis and Bristol Myers Squibb announced a temporary halt to several CAR-T cell therapy trials targeting autoimmune diseases.

The pause involves Novartis’s autologous CD19 CAR-T candidate rapcabtagene autoleucel (rap-cel; YTB323) across phase 2 studies in lupus, systemic sclerosis, ANCA-associated vasculitis, idiopathic inflammatory myopathies, and phase 1/2 studies in rheumatoid arthritis, Sjogren’s disease, generalized myasthenia gravis, relapsing multiple sclerosis and progressive multiple sclerosis.

The decision follows three serious immune effector cell-associated hemophagocytic syndrome events, prompting a comprehensive safety review. Novartis emphasized patient safety as the top priority.

The halt is described as temporary while the evolving clinical and safety data are evaluated, with no indication that the programs have been terminated.