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news.Juno Therapeutics has voluntarily placed on hold the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, known as the “ROCKET” trial.
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The clinical hold was initiated after two patients suffered cerebral edema earlier this week. One patient died and as of last night the other is not expected to recover.
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.