Novartis and Bristol Myers pause autoimmune CAR-T trials after safety concerns

Novartis announced a temporary hold on its personalized CAR-T therapy rap-cel after three patients experienced immune effector cell-associated hemophagocytic syndrome, a rare and potentially life-threatening reaction. The hold affects studies in lupus, myasthenia gravis, multiple sclerosis and other autoimmune indications and was put in place on Aug. 24.

The company said it is working with regulators to review the emerging safety data and will reassess the program before resuming enrollment.

Bristol Myers Squibb also voluntarily paused enrollment in its autoimmune CAR-T program using zolacabtagene autoleucel (zola-cel). The decision was communicated to investigators following the same safety concerns, although specific adverse events were not detailed.

Both companies emphasized that the pauses are precautionary and aim to ensure patient safety while they evaluate the clinical findings further.