Novartis temporarily paused eight clinical trials of its experimental CAR-T therapy in late August after three patients died from a severe immune response, The Wall Street Journal reported Sept. 1.
The Switzerland-based drugmaker was testing the treatment — called rap-cel — in patients with lupus, multiple sclerosis and other autoimmune disorders. The timeline of the deaths was not immediately clear.
A Novartis spokesperson told the Journal that it’s conducting “a comprehensive review of the observed safety events.” The drugmaker is working closely with regulators and the independent safety boards overseeing each paused study, the spokesperson added.
Bristol-Myers Squibb also paused trials of its similar CAR-T treatment, zola-cel, for autoimmune disorders as a precaution. The New Jersey-based drugmaker said it paused the program during a regular protocol review after researchers identified “transient and reversible inflammatory events.”
“We are focused on completing our evaluation and resuming enrollment as quickly as possible,” a Bristol-Myers Squibb spokesperson told the Journal. Both rap-cel and zola-cel target CD19, a protein on certain immune cells.
Fatal immune responses can occur in patients receiving CAR-T therapies when reinfused immune cells overreact, triggering inflammation that can damage organs, according to the report. These risks have been previously documented in CAR-T cancer patients.
Novartis’ trials of rap-cel in cancer patients are ongoing.
Novartis and Bristol-Myers Squibb each already market separate one-time CAR-T therapies for cancer that cost more than $500,000 per treatment.
Editor’s note: Becker’s has reached out to Novartis and Bristol-Myers Squibb for comment and will update the article if more information becomes available.
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