The U.S. Food and Drug Administration placed a hold on a Juno Therapeutics clinical trial of a treatment for a form of leukemia following the death of two trial patients last week.
The Company said in a press announcement that both deaths occurred last week after the patients, who had relapsed or refractory B cell acute lymphoblastic leukemia, took the drug fludarabine before receiving the chimeric antigen receptor (CAR) T cells that Juno had taken from their bodies and re-engineered to better attack cancer cells. Another patient had died earlier in the trial, but “confounding factors” spurred Juno to continue with the study at that time
Juno announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial.
Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested that Juno submit, as a Complete Response to the Clinical Hold several items including a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency yesterday. Juno stated they will submit the requested information to the FDA this week.
Juno’s trials and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected.