Novartis and Bristol Myers Squibb pause autoimmune cell therapy trials due to inflammatory side effects

Novartis suspended trials for its personalized cell therapy, rapcabtagene autoleucel (rap-cel), in multiple indications including lupus, myasthenia gravis, and multiple sclerosis. This decision was prompted by three cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS), a rare and potentially life-threatening reaction that resulted in fatalities. Novartis is currently reviewing the safety data and engaging with independent data committees to develop improved safety measures. Bristol Myers Squibb voluntarily paused enrollment in trials for its CAR-T treatment zolacabtagene autoleucel (zola-cel) out of an abundance of caution. The company detected transient and reversible inflammatory events during routine safety surveillance. While Bristol Myers Squibb did not report deaths linked to zola-cel, at least one case of IEC-HS was previously reported in a Phase 1 study. Both companies are evaluating the clinical data to determine the cause of the side effects and aim to resume testing as quickly as possible.