Juno Therapeutics, Inc., has voluntarily placed on hold the phase 2 clinical trial of JCAR015 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia, known as the “ROCKET” trial. The clinical hold was initiated after two patients suffered cerebral edema earlier in the week. One patient died and the other is not expected to recover.
Juno has notified the FDA of the voluntary hold and is working with the agency and the Data and Safety Monitoring Board to determine next steps. The company is assessing data from the cases and the trial and is evaluating its options regarding the JCAR015 program.
The FDA initially placed a clinical hold on the ROCKET trial in early July after two patients died following the addition of fludarabine to the preconditioning regimen. The trial was permitted to continue in mid-July after submission to the FDA of a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency after the hold,.
Juno’s trials and plans for its other CD19-directed CAR T-cell product candidates, including JCAR017, are not affected.