Novartis pauses autoimmune CAR T trials following three deaths The first gene therapy for Huntington's disease submitted to the FDA, an mRNA flu vaccine advances to Phase 3 trials, an antibody drug for celiac disease, and more led the news this week. Brought to you byDDN editorial team

Novartis pauses autoimmune CAR T trials following three deaths The first gene therapy for Huntington's disease submitted to the FDA, an mRNA flu vaccine advances to Phase 3 trials, an antibody drug for celiac disease, and more led the news this week. Brought to you byDDN editorial team https://www.drugdiscoverynews.com/novartis-pauses-autoimmune-car-t-trials-following-three-deaths-17501 Novartis has hit the brakes across eight early- and mid-stage trials of its experimental CD19-directed CAR T therapy rapcabtagene autoleucel (rap-cel). The company made the move after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS), a rare but potentially fatal hyperinflammatory complication of CAR T treatment. The pause affects the therapy’s immunology and neuroscience programs, including Phase 2 AUTOGRAPH studies in systemic lupus erythematosus, lupus nephritis, systemic sclerosis, ANCA-associated vasculitis, and idiopathic inflammatory myopathies, as well as Phase 1/2 trials in rheumatoid arthritis, Sjögren’s disease, myasthenia gravis, and multiple sclerosis. Novartis’ oncology studies of rap-cel remain ongoing. The move comes as drugmakers increasingly explore CAR T beyond cancer, raising new questions about how the therapy’s potentially serious toxicities can be managed in autoimmune diseases. Bristol Myers Squibb has also paused enrollment in its autoimmune studies of zolacabtagene autoleucel (zola-cel) after observing transient, reversible inflammatory events, although the company is still conducting the trials. – Bree Foster