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Another Death Reported in Juno's CAR-T Trial in Patients With ALL
Within 4 months of the last reported incident, Juno Therapeutics has again halted the phase 2 “Rocket” trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
It happened again. Within 4 months of the last reported incident, Juno Therapeutics has again halted the phase 2 “Rocket” trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
In a call with investors and in a statement, the company reported that 1 patient on the trial died earlier in the week as a result of cerebral edema, while another, facing similar symptoms, is not expected to recover.
Juno, a pioneer in developing the chimeric antigen receptor T (CAR-T) cell therapy, had to halt the Rocket trial in July this year following the death of 3 patients who were enrolled in the JCAR015 trial, which used fludarabine/cyclophosphamide during the preconditioning step. Mark Gilbert, MD, senior vice president and chief medical officer at Juno, had said during a subsequent conference call that the company would propose removing fludarabine from the procedure.
Following a meeting with the FDA, the trial was restarted.
During today’s call, Hans Bishop, CEO of Juno, said, “These are obviously difficult times for us. Adult ALL is proving to be a difficult disease, but we really are not ready to give up on it.”
While the company will be in discussions with the FDA on next best steps, it plans to continue work on its other CD19-directed CAR-T cell products.
FDA Expands Access to Approved CAR T-Cell Therapies by Eliminating REMS
June 30th 2025The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and expand patient access.
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