Bristol Myers pauses enrollment in zola-cel autoimmune trials after inflammatory events

Bristol Myers Squibb/Zola-cel (BMS-986353)

BMS voluntarily paused new enrollment, but not ongoing treatment, in its zola-cel autoimmune studies after routine safety checks found transient, reversible inflammatory events. It came as Novartis put eight autoimmune trials of its own CAR-T, rap-cel, on hold after three deaths. BMS said it still has confidence in zola-cel and aims to resume enrollment quickly.

• BMS framed the pause as a precaution while it reviews safety data from all zola-cel studies.
• One case of the rare hyper-inflammation syndrome IEC-HS had been disclosed earlier in Phase 1.
• Novartis's holds cover lupus, myasthenia gravis, multiple sclerosis and other indications.