Novartis pauses eight rap-cel trials after three patient deaths

Bern, Switzerland. Novartis paused eight clinical trials of its experimental CAR T-cell therapy rap-cel in late August after three patients died from complications linked to a severe immune reaction. Bristol Myers also voluntarily paused studies of its rival CAR T-cell treatment zola-cel while reviewing safety data.

Trial suspension and safety review

Novartis implemented the halt on August 24 after being notified of three cases of a severe, life-threatening immune reaction. The reaction causes the immune system to overreact and attack the body’s own organs, and complications led to the deaths, the Swiss drugmaker said.

The company said it is conducting a comprehensive review of the deaths with independent safety boards. It is also examining ways to identify dangerous side effects earlier.

Novartis said it is sharing information with health authorities and will continue monitoring patients who have already received rap-cel.

Studies affected

The suspended trials include studies involving inflammatory diseases such as lupus, rheumatoid arthritis and vasculitis, as well as multiple sclerosis and myasthenia gravis, which can weaken nerves and muscles.

Two Novartis trials involving patients with lymphoma and leukemia were not affected by the pause.

Novartis said severe immune reactions are a known and potentially life-threatening risk of CAR T-cell therapy.

CAR T-cell treatments

CAR T-cell therapy involves removing a patient’s immune cells, modifying them to recognise and destroy specific target cells, and reinfusing them into the patient. The treatment approach has shown success in blood cancers and is increasingly being tested for autoimmune and other conditions.

Bristol Myers said it had paused studies of zola-cel out of an abundance of caution as it reviews safety information.

Market response

Novartis shares rose 4% on Tuesday, as investors focused on the late-stage success of its oral multiple sclerosis drug remibrutinib. The Wall Street Journal first reported the rap-cel trial halt.