CAR-T Therapy Trial Halted Due to Patient Deaths

The phase II ROCKET trial of JCAR015, an investigational chimeric antigen receptor (CAR), was halted again due to two additional patient deaths. The trial was halted earlier this year due to other patient deaths, but the U.S. Food and Drug Administration (FDA) allowed the trial to resume after Juno Therapeutics – the drug’s manufacturer – argued that the deaths were related to the addition of fludarabine to the pre-conditioning regimen. The trial continued with cyclophosphamide as a substitution for fludarabine.

The two recent deaths were related to cerebral edema. According to the JCAR015’s manufacturer, these deaths appear to be correlated with the rapid proliferation of CAR-T cells injected back into the body.

Juno Therapeutics reported that it notified the FDA of the voluntary hold and is working with the agency and the Data and Safety Monitoring Board to determine next steps.

Source: Juno Therapeutics press release, November 23, 2016.

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