Novartis halted several CAR-T trials in autoimmune diseases after observing immune-related adverse events, and Bristol Myers Squibb also paused its zola-cel program for safety review. The actions reflect growing scrutiny of off-the-shelf and next-generation cell therapies as trial programs broaden beyond oncology. Novartis’ pauses cover rap-cel development across multiple indications, while BMS’ voluntary pause applies to autoimmune testing of zola-cel. Both companies said the decisions follow safety findings requiring additional assessment. The pauses add pressure to CAR-T programs designed to target immune pathways in non-malignant settings, where benefit-risk thresholds may be more stringent and safety signals can trigger rapid operational changes.
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