Novartis Halts CAR-T Trials Following Patient Deaths from Inflammatory Condition
Novartis has paused eight clinical trials for its experimental CAR-T therapy, rapcabtagene autoleucel (rap-cel or YTB323), after three patients died from immune effector cell-associated haemophagocytic syndrome (IEC-HS). This severe inflammatory condition, a known complication of CAR-T therapy, causes engineered immune cells to multiply rapidly, leading to widespread organ and tissue damage. The affected trials were in the immunology and neuroscience areas, testing the therapy for various autoimmune diseases such as rheumatoid arthritis, Sjögren's disease, systemic sclerosis, lupus, and multiple sclerosis. Novartis confirmed the halt of screening, patient randomization, and dosing on August 24th, while continuing studies in cancer indications. The company has initiated a comprehensive review to determine the future of these trials. In a related development, Bristol Myers Squibb (BMS) also voluntarily paused enrollment in its own CD19-directed CAR-T clinical trials for autoimmune diseases, zolacabtagene aut... 
