Novartis CAR-T trial deaths spark safety concerns for autoimmune applications

Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investigation.

Scientists have long viewed CAR-T technology as a possible breakthrough for treating autoimmune conditions, offering a targeted approach that could replace broader immunosuppressive drugs. The recent fatalities, however, underscore the potential for severe adverse events when the therapy is applied outside oncology.

The events are likely to prompt regulators and Novartis to re-evaluate the risk-benefit balance for autoimmune indications. Adjustments to trial protocols, patient selection criteria, and monitoring may be required before further development proceeds.