Novartis paused eight clinical trials of an experimental therapy targeting autoimmune and neurological disorders in late August, after three patients died. According to a Wall Street Journal report published Tuesday, the Swiss pharmaceutical company temporarily halted the studies once it learned of three fatal cases involving a severe immune response.
The experimental treatment is called chimeric antigen receptor T-cell therapy, or CAR-T. These therapies work by modifying a patient’s own immune cells to recognize a specific target and destroy diseased cells. Although CAR-T originally emerged as a breakthrough cancer treatment, researchers have increasingly explored its potential against autoimmune and neurological conditions, making these trials part of a closely watched expansion into new disease areas.
It was not immediately clear when the three deaths occurred. However, the company confirmed it is now conducting what it described as a comprehensive review of the observed safety events. A Novartis spokesman characterized the fatal immune response as a known safety risk in CAR-T therapies, indicating the deaths, while serious, fell within recognized dangers associated with this class of treatment.
Novartis said it is working alongside the independent safety boards overseeing each paused study. Additionally, the company stated it is sharing what it currently knows with regulators, a standard step when serious adverse events interrupt ongoing clinical research.
The pause extends beyond Novartis alone. Bristol-Myers Squibb had also paused similar trials of its own CAR-T treatment in autoimmune disorders, adopting the halt as a precautionary measure. Because two major pharmaceutical companies suspended comparable programs around the same period, the developments raise broader questions about the safety profile of CAR-T therapies as they move beyond oncology.
Both Novartis and Bristol-Myers Squibb did not immediately respond to Reuters requests for comment regarding the paused trials and their next steps.
