Novartis and BMS Pause Autoimmune CAR-T Trials After Safety Events
- Novartis and Bristol Myers Squibb separately paused clinical trials of experimental autologous CAR-T cell therapies being developed for autoimmune and neurological conditions, including lupus, rheumatoid arthritis, vasculitis, multiple sclerosis and myasthenia gravis.
- Novartis halted eight studies of its candidate, rap-cel (rapcabtagene autoleucel), around August 24 after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS), a severe systemic inflammatory reaction.
- Bristol Myers Squibb paused enrollment in trials of its own CD19-targeted CAR-T, zola-cel, describing "transient and reversible inflammatory events" markedly less severe than the deaths Novartis reported, and saying the therapy's safety profile otherwise remains consistent with other CAR-T treatments.
- Both companies said they are reviewing clinical data with independent safety boards and regulators before deciding on next steps for their affected programs.
Autoimmune CAR-T was the industry's hottest oncology-to-new-indication pivot — Kyverna, Cabaletta, Autolus and multiple academic programs are all racing the same CD19 mechanism, so this becomes a class-level scrutiny event, not just a Novartis/BMS problem. The two signals aren't equivalent: three IEC-HS deaths is a materially different regulatory conversation than BMS's "reversible" events — expect FDA to treat rap-cel far more cautiously than zola-cel, even though headlines pair them. Multi-trial pauses cost both companies precious time on programs meant to diversify beyond their legacy oncology CAR-T franchises (Kymriah, Breyanzi) into a much larger chronic-disease market. If regulators respond with class-wide holds or REMS-style safeguards, smaller autoimmune CAR-T players inherit the delay and diligence burden without the balance sheets to absorb it.
UPDATED: Novartis halts autoimmune CAR-T trials after 3 deaths, as BMS also pauses studies ↗