Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused

Novartis has halted trials of its CD19-directed CAR-T therapy after three patients died following a dangerous immune system response, according to Endpoints News. The treatment engineers a patient’s own T cells to target cancer cells bearing the CD19 marker, a technique used against certain blood cancers.

Endpoints reports that a similar therapy from Bristol Myers Squibb has also been paused, with the company reviewing safety issues in its own program.

CAR-T therapies carry known risks of severe immune reactions, including cytokine release syndrome, in which activated immune cells trigger a systemic inflammatory response that can become life-threatening. The three deaths in the Novartis trials are described as resulting from such a reaction.

The report does not specify the total number of patients enrolled in the affected trials, the exact timeline of the three deaths, or the specific safety concerns prompting the Bristol Myers pause. Nor does it detail what regulatory bodies, if any, have been formally notified or what steps either company plans before resuming its program.

Both pauses come amid continued clinical development of CD19-directed CAR-T treatments, a class of therapy that has expanded rapidly in oncology in recent years. Endpoints News did not report further details on the mechanism of the Bristol Myers safety review at the time of publication.