Novartis pauses trials of experimental cell therapy after three deaths

Novartis said it was conducting a comprehensive review of the deaths and is working with independent safety boards to look into what happened as well as to find ways to catch dangerous side effects earlier.

Novartis said its two trials in patients with lymphoma and leukemia were not affected by the halt.

The drugmaker said that this type of severe immune reaction is a known, potentially life-threatening risk of CAR T therapy. Novartis added that it is actively sharing information with health authorities and will continue to monitor patients who have already received the treatment.

The trials affected include those for inflammatory diseases such as lupus, rheumatoid arthritis, and vasculitis and nerve- and muscle-weakening disorders including multiple sclerosis and myasthenia gravis.

Rap-cel is a type of CAR T-cell therapy, a relatively new type of treatment in which a patient's immune cells are removed, modified to recognise and destroy specific target cells, and reinfused. The complex process has seen success with blood cancers, and drugmakers have more recently been testing these therapies for autoimmune and other conditions.