Nov. 23, 2016– Juno Therapeutics, Inc. announced that it has voluntarily halted the Phase II clinical trial of JCAR015, known as the “ROCKET” trial. The clinical hold was initiated after two patients suffered cerebral edema earlier this week and died.
The trial was temporarily halted in July, at which time Juno pointed to fludarabine, a drug being given as part of the therapy, as a potential cause of the brain swelling. “Cutting out fludarabine helped but wasn’t sufficient”, Chief Executive Officer Hans Bishop said. “It undoubtedly contributed in the way we expected, it just hasn’t gotten us as far as we hoped it would,” he said.
The company may test the therapy further in ALL, said Chief Medical Officer Mark Gilbert. “We see a likely path forward for JCAR015 in ALL,” Gilbert said, though “it’s still too early” to be sure what it would look like.
The patients enrolled in this Phase II trial are adults with relapsed or refractory B cell acute lymphoblastic leukemia.
Juno has notified the Food & Drug Administration 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.
Juno’s trials and plans for its other CD19-directed CAR T cell product candidates, including JCAR017, are not affected.