CAR T-Cell Trials for Autoimmune Diseases Paused After Safety Events

CAR T-cell therapies have made tremendous progress in treating cancers and investigators are now looking at how they can be used to eliminate cells responsible for autoimmune reactions. Such therapies are designed to eliminate self-targeting B cells and subsequently allow the immune system to rebuild itself without these dysfunctional B cells.

These trials have been underway at Novartis and BMS, which have been working on separate trials that investigated CAR T-cell therapies for a number of autoimmune diseases. Both companies have recently paused these efforts.

The Novartis trials have resulted in three deaths related to immune effector cell-associated hemophagocytic syndrome (IEC-HS), a life-threatening inflammatory reaction that can occur after CAR T-cell therapy. Trials paused include Phase 1 and 1/2 studies for a variety of indications like systemic lupus erythematosus, rheumatoid arthritis, and Sjogren disease.

This pause will allow them to more comprehensively review clinical and safety data.

BMS has also paused CAR T studies for autoimmune diseases due to “transient and reversible inflammatory events” but have not reported any associated fatalities.

This type of immune reaction to CAR T-cell therapies has already been identified in cancer applications. It’s a known, uncommon, but life-threatening complication of CAR T-cell therapy. These pauses don’t determine whether CAR T-cell therapies can be effective for treating autoimmune diseases, but raises the question of how the potential long-term benefit of resetting the immune system should be weighted against the risks.

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Citations

Lee, J. C., Johnson, W. T., Hines, M., & Shah, N. N. (2025). Immune Effector Cell-associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS). Hematology/oncology clinics of North America, 39(3), 617–643. https://doi.org/10.1016/j.hoc.2025.02.005

Russo, M.  (2026, August 31). UPDATED: Novartis halts autoimmune CAR-T trials after 3 deaths, as BMS also pauses studies. Fierce Biotech. https://www.fiercebiotech.com/biotech/novartis-bristol-myers-squibb-halt-car-t-cell-trials-due-immune-events