Novartis, BMS Pause Autoimmune CAR-T Trials After Deaths

Novartis has paused eight clinical trials of an experimental cell therapy for autoimmune and neurological diseases after three patients died from a severe immune reaction, a setback for a promising approach to treating conditions like lupus and multiple sclerosis. The Swiss pharmaceutical company confirmed it halted studies of rapcabtagene autoleucel, known as rapcel, on August 24 following the fatal cases. Bristol Myers Squibb also announced a voluntary pause in enrollment for its similar therapy, zolacabtagene autoleucel or zolacel, as a precautionary measure. The deaths were linked to immune effector cell-associated hemophagocytic syndrome, or IECHS, a severe inflammatory complication where the body's immune system overactivates and begins attacking its own blood cells and organs. Novartis described this as a known, potentially life-threatening risk of CAR-T therapies, which modify a patient's own immune cells to target specific cells. The company is conducting a comprehensive review with independent safety boards and regulators but has not disclosed when the deaths occurred or detailed the individual cases.