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Juno Therapeutics Places JCAR015 Phase II ROCKET Trial on Clinical Hold
Nov. 23, 2016 08:55AM PST
Biotech InvestingJuno Therapeutics today announced that it has elected to place a Phase II clinical trial of JCAR015 on hold. The pause comes after two patients suffered cerebral edema, in one case leading to death.
Juno Therapeutics (NASDAQ:JUNO) today announced that it has elected to place a Phase II clinical trial of JCAR015 on hold. The pause comes after two patients suffered cerebral edema, in one case leading to death.
According to the press release:
“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.”
The press release goes on to note:
“Juno’s trials and plans for its other CD19-directed CAR T cell product candidates, including JCAR017, are not affected.”