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Getting the latest healthcare news for you
Getting the latest healthcare news for you
Novartis hits pause on eight CAR T-cell therapy trials after three patients died from severe immune reactions. The halted trials covered conditions like lupus, rheumatoid arthritis, MS, and myasthenia gravis. Bristol Myers Squibb also paused its comparable CAR T program as a precaution, sending ripples through the emerging field of cellular therapy for autoimmune diseases.
Novartis paused eight clinical trials of its experimental CAR T-cell therapy, rapcabtagene autoleucel (rap-cel), on August 24 after three patients died from a severe, life-threatening immune reaction. The affected trials spanned a range of autoimmune and neurological conditions — including lupus, rheumatoid arthritis, vasculitis, multiple sclerosis, and myasthenia gravis. Two rap-cel trials in lymphoma and leukemia patients were not affected.
In response, Bristol Myers Squibb also voluntarily paused its own comparable CAR T program — zolacabtagene autoleucel (zola-cel) — as a precautionary measure. Experts believe both therapies' rapid manufacturing platforms may be producing T cells that expand too aggressively in patients, potentially triggering a dangerous inflammatory syndrome known as IEC-HS (immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome).
Key Takeaways:
Why it matters: CAR T-cell therapy has shown remarkable, drug-free remissions in autoimmune patients who had exhausted other options. These deaths don't erase that promise, but they underscore the urgent need to refine patient selection, manufacturing processes, and safety monitoring before the field can move forward confidently.
