ARTICLE | Clinical News

19-28z CAR T cells: Phase II halted

July 11, 2016 7:00 AM UTC

Juno said FDA halted the open-label, U.S. Phase II ROCKET trial evaluating IV JCAR015 following 2 patient deaths from cerebral edema. Juno said a third ROCKET patient died with cerebral edema in May, but FDA and a DSMB concluded there were “confounding factors” and changes to the trial were not warranted as a result of that death. Juno said the most likely contributor to the patient deaths was the addition of fludarabine to the study’s preconditioning regimen. All 3 patients who died were receiving the purine nucleotide analog in combination with cyclophosphamide.

The company said >20 patients had been treated in the study, with about a third receiving fludarabine and cyclophosphamide and the remainder receiving cyclophosphamide alone. Juno said the fludarabine/cyclophosphamide-treated patients showed a more rapid expansion of T cells than those who received cyclophosphamide alone, which contributed to the neurotoxicity. ...