Following the death of three patients who were part of an experimental cell therapy called rap-cel, Novartis decided to pause eight clinical trials. Rap-cel is a type of CAR T-cell therapy in which a patient's immune cells are removed, modified to recognise and destroy specific target cells, and reinfused.
The trials were focused on targeting autoimmune and neurological disorders and had to be halted following the deaths in August due to a severe, life-threatening immune reaction.
According to the Swiss drugmaker, complications from the reaction, in which the body's defense system overreacts and attacks its own organs, led to the deaths.
U.S. drugmaker Bristol Myers also said it has implemented a voluntary pause on studies for a rival CAR T-cell treatment, zola-cel, "out of an abundance of caution" as it reviews safety data, Reuters reported.
Officials at Novartis also said that they were conducting a comprehensive review of the deaths and are also looking into what happened, as well as to find ways to catch dangerous side effects earlier.
As per Reuters, Novartis said that it is actively sharing information with health authorities and will continue to monitor patients who have already received the treatment.
The halted trials include those for inflammatory diseases such as lupus, rheumatoid arthritis, and vasculitis and nerve- and muscle-weakening disorders including multiple sclerosis and myasthenia gravis.
