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Novartis, Bristol Myers Pause Cell Therapy Trials After Three Patient Deaths
Novartis and Bristol Myers Squibb have halted multiple autoimmune cell therapy trials after inflammatory side effects emerged, including three patient deaths from immune reactions in Novartis trials of CAR-T candidate rap-cel. Bristol Myers voluntarily paused enrollment in autoimmune trials for its CAR-T treatment zola-cel. Both therapies use accelerated production technology compared to earlier CAR-T products. The pauses affect investigational treatments not yet approved for any indication, with unclear timelines for resumption.
Why it mattersThese trial holds may delay potential Medicaid coverage decisions for autoimmune CAR-T therapies and raise safety questions about accelerated manufacturing processes that could affect future utilization management policies for cell therapies covered under Medicaid.