Swiss pharmaceutical company Novartis has suspended eight clinical trials of the experimental therapy rap-cel, intended to treat autoimmune and neurological diseases. The decision was made on 24 August following the deaths of three patients.

All of the affected patients experienced a severe, life-threatening immune system reaction in which the body’s defense mechanisms overreact and attack its own organs. This complication is one of the known risks of CAR-T cell therapy.

The suspended trials involve lupus, rheumatoid arthritis, vasculitis, multiple sclerosis and myasthenia gravis. Two studies involving patients with lymphoma and leukemia are continuing without restrictions.

Novartis has launched a comprehensive investigation into the deaths and is collaborating with independent safety committees. It is also seeking ways to detect dangerous side effects earlier. It is providing information to health authorities and continues to monitor people who have already received the treatment.

In this method, doctors remove the patient’s immune cells, modify them so that they recognize and destroy selected target cells and then return them to the body.

Bristol Myers has also voluntarily halted trials of the competing treatment, Zola-Cel, as a precautionary measure. Patients in those trials experienced temporary and reversible inflammation. The company is now reviewing the safety data.

(Reuters, bak)