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Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns
BioPharma Dive • • business
Key Points:
- Novartis and Bristol Myers Squibb have paused multiple autoimmune trials of their cell therapies, rap-cel and zola-cel, respectively, after observing inflammatory side effects including immune effector cell-associated hemophagocytic syndrome (IEC-HS).
- Novartis halted rap-cel trials on August 24 to review safety data across studies in lupus, myasthenia gravis, multiple sclerosis, and other conditions, while Bristol Myers paused enrollment in zola-cel trials as a precaution to evaluate transient inflammatory events.
- Both companies emphasize ongoing engagement with regulators and aim to resume trials quickly after comprehensive safety reviews; Bristol Myers maintains confidence in zola-cel’s safety profile and therapeutic potential.
- Rap-cel and zola-cel utilize advanced CAR-T technology designed to speed production but may contribute to increased cell expansion and related toxicities, according to analyst commentary.
- These developments highlight challenges in adapting CAR-T therapies for autoimmune diseases, a growing research area with multiple companies pursuing similar treatments for conditions like lupus, myositis, and myasthenia gravis.
