Novartis paused eight autoimmune and neurological rap-cel CAR-T trials after three patients died from a rare, severe immune reaction. Bristol Myers paused new enrollment in zola-cel trials after events it called transient and reversible; it reported no deaths.
The deaths were from immune effector cell-associated hemophagocytic syndrome, described as a rare, severe immune reaction. Two Novartis rap-cel studies in lymphoma and leukemia were outside the pause and remain ongoing.
Bristol Myers informed regulators and researchers in early June, but the public was not informed until about three months later, according to the article. Novartis confirmed its pause after an analyst noticed halted trials in a public database; the company disclosed the deaths a week later.
