Clinical trials for autoimmune therapy paused after three patients die — report

Novartis NOVN.S paused eight clinical trials of an experimental therapy targeting autoimmune and neurological disorders in late August, after three patients died, the Wall Street Journal reported on Tuesday.

The Swiss pharmaceutical company temporarily halted the studies after learning of three fatal cases of a severe immune response, the report said, citing a spokesman. It wasn’t immediately clear when the deaths occurred.

The experimental treatment is called chimeric antigen receptor T-cell, or CAR-T.

CAR-T therapies modify a patient's immune cells to recognize a specific target and destroy cancer cells.

Novartis is conducting “a comprehensive review of the observed safety events,” the spokesman told WSJ, describing the fatal immune response as a known safety risk in CAR-T therapies.

According to the report, the company said it is working with independent safety boards overseeing each paused study and sharing what it knows with regulators.

Bristol-Myers Squibb BMY.N had also paused similar trials of its CAR-T treatment in autoimmune disorders as a precautionary measure, the newspaper said.

Novartis and BMY did not immediately respond to Reuters requests for comment.

-Reporting by Shivani Tanna in Bengaluru; Editing by Janane Venkatraman and Mrigank Dhaniwala/Reuters