Novartis has halted eight clinical trials of an experimental cell therapy after three patients died, it announced on Tuesday.
The Swiss drugmaker paused the trials on August 24, reporting that they were alerted to three cases of severe, life-threatening immune reactions in participants of a cell therapy trial targeting autoimmune and neurological disorders. All three patients died.
Following the unexpected deaths, which reportedly occurred as a result of complications following immune reactions in which the body’s defence system attacked its own organs, Novartis has launched a “comprehensive” review of the events.
The trial was for rap-cell, a type of CAR-T therapy which modifies a patient’s immune cells to train them to recognise and destroy specific cells. While traditionally used in the treatment of blood cancers, these therapies are being increasingly tested for autoimmune and other conditions.
Working alongside independent safety boards to examine what happened, the company is also reviewing whether there are ways the dangerous side effects of the treatment can be caught earlier.
Novartis said that this type of severe, life-threatening immune reaction is a known risk of CAR-T therapy, adding that it is actively sharing information with health authorities and will continue to monitor closely patients who have already received the treatment as part of the trial.
The trials affected include those for inflammatory diseases including lupus, rheumatoid arthritis, and vasculitis, as well as nerve and muscle weakening disorders such as multiple sclerosis and myasthenia gravis.
It was noted that the two separate trials the drugmaker is carrying out in patients with lymphoma and leukemia are not affected by the halt and will continue as planned.
Despite the unfortunate events, Novartis’s shares were up 4% on Tuesday, a major reason being its positive data for a phase 3 trial of remibrutinib, an oral multiple-sclerosis treatment.
The new drug beat the older treatment teriflunomide in reducing relapses, strengthening expectations that it could become a significant blockbuster for the company.
Bristol Myers Squibbs have also reportedly paused similar trials of its CAR-T therapy in autoimmune disorders as a precautionary measure.
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