19-28z CAR T cells: Phase II resumed

Juno said that FDA lifted a clinical hold on the open-label, U.S. Phase II ROCKET trial evaluating IV JCAR015. FDA placed the hold on July 7 after the company reported 2 deaths from cerebral edema in patients pre-conditioned with fludarabine (see BioCentury, July 11). Juno revised ROCKET’s protocol by eliminating fludarabine treatment from the preconditioning regimen but continuing with the cyclophosphamide regimen. 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, and that the trial will enroll up to 110 patients. ...