After the U.S. Food and Drug Administration (FDA) placed a phase II chimeric antigen receptor (CAR) trial on clinical hold due to patient deaths, the trial has been allowed to resume – with certain modifications.
On July 7, 2016, the FDA suspended the ROCKET trial, which was evaluating the investigational CAR JCAR015 for the treatment of adult patients with relapsed/refractory B-cell acute lymphocytic leukemia. The hold was initiated after two patient deaths (due to cerebral edema) were reported. The drug’s manufacturer – Juno Therapeutics, Inc. – reported that the deaths were related to the addition of fludarabine to the pre-conditioning regimen, and proposed that the trial continue with cyclophosphamide as a substitution. On July 12, 2016, after the manufacturer made the FDA’s requested revisions to the trial’s patient informed consent form, investigator brochure, and trial protocol, the agency allowed the trial to resume.
Sources: Juno Therapeutics news release, July 7, 2016; The New York Times, July 12, 2016.