Novartis pauses eight clinical trials of experimental cell therapy after three patient deaths

Novartis (NVS) has suspended eight clinical trials of its experimental cell therapy rap-cel, which targets autoimmune and neurological disorders, after three patients died following a severe immune reaction, the Swiss drugmaker disclosed.

The halt was implemented on August 24 after Novartis was notified of three cases of a life-threatening immune overreaction in which the body's defense system attacks its own organs. The company said it is conducting a comprehensive review of the deaths in conjunction with independent safety boards, and is working to identify ways to detect dangerous side effects earlier.

Bristol Myers Squibb (BMY) said it had separately implemented a voluntary pause on studies of its rival CAR T-cell therapy, zola-cel, as it reviews safety data. A spokesperson said patients in those trials experienced temporary, reversible inflammation and that the drug's overall safety profile remains consistent with other CAR T therapies.

Rap-cel is a form of CAR T-cell therapy, a relatively new treatment modality in which a patient's immune cells are extracted, genetically modified to recognize and destroy specific target cells, and reinfused. The approach has demonstrated success in blood cancers, and drugmakers have more recently been exploring its application in autoimmune and other conditions. Novartis acknowledged that severe immune reactions represent a known, potentially life-threatening risk of CAR T therapy, and said it is actively sharing information with health authorities while continuing to monitor patients already treated.

The suspended trials cover inflammatory diseases including lupus, rheumatoid arthritis and vasculitis, as well as nerve- and muscle-weakening conditions such as multiple sclerosis and myasthenia gravis. Novartis said its two oncology trials — in patients with lymphoma and leukemia — were not affected by the pause.