Novartis halts eight CAR-T trials after three immune deaths

Novartis initiated holds on 24 August 2026 across trials of rap-cel, its CAR-T cell therapy aimed at autoimmune and neurological disease, after three cases of immune effector cell-associated hemophagocytic syndrome. Reuters reported on 1 September that the three cases were fatal, and that eight studies were paused. The affected phase 2 programmes include systemic lupus erythematosus and lupus nephritis, systemic sclerosis, ANCA-associated vasculitis and idiopathic inflammatory myopathies.

A Novartis spokesperson told BioPharma Dive the temporary halt would allow a more comprehensive review of the evolving clinical and safety data across the programme. The company says it is engaged with regulators and independent safety boards, and will keep monitoring patients already dosed.

Bristol Myers Squibb voluntarily paused enrolment in its own autoimmune trials of zolacabtagene autoleucel, describing transient and reversible inflammatory events and saying it acted out of an abundance of caution. Its trials were not halted outright.

Reprogrammed T cells were being turned from a cancer treatment into a way to reset an autoimmune system — the largest current attempt to make engineered cells a general-purpose repair tool. Hemophagocytic syndrome is a recognised risk of CAR-T. Its arrival in patients who do not have cancer is what changes the arithmetic.