2 Companies Pause Some CAR T Studies

Novartis and Bristol Myers Squibb have each paused some studies of CAR T candidates while adverse events are evaluated. BioSpace reports Novartis suspended multiple studies of its rapcabtagene autoleucel (rap-cel) after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome.

Meanwhile, the report says, BMS froze some autoimmune trials of its zolacabtagene autoleucel (zola-cel) after observing transient irreversible inflammatory events.

The Novartis pause reportedly affects the Phase 2 AUTOGRAPH studies in various autoimmune conditions. The company also is said to be suspending Phase 1/2 trials of rap-cel’s safety, efficacy, and cellular kinetics in patients with rheumatoid arthritis, generalized myasthenia gravis, and certain types of multiple sclerosis. Cancer studies are not affected by the pause, Novartis told BioSpace. The report says it is unclear which BMS studies are part of the suspension.