Autoimmune CAR-T Trials Halt After Fatal IEC-HS Events

Novartis has temporarily paused its autologous CD19 CAR-T program for autoimmune diseases after three IEC-HS–related deaths, affecting multiple phase 1/2 studies across lupus, systemic sclerosis, ANCA-associated vasculitis, myopathies and other conditions, with patient monitoring continuing. Bristol Myers Squibb has also paused enrollment in its autologous CD19 zola-cel autoimmune trials due to transient inflammatory events, though oncology programs remain active. Analysts suggest rapid manufacturing platforms (T-Charge, NEXT-T) may drive increased T‑cell expansion and toxicities, prompting a cautious safety review before resumption.