The FDA has placed a clinical hold on Juno Therapeutics’ Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
The clinical hold was initiated after 2 patients died in the trial last week following the recent addition of fludarabine to the pre-conditioning regimen. A third patient died in May. All 3 patients were in their 20s and the deaths were linked to swelling in the brain.
In a press release
, Juno stated they have proposed to the FDA to continue the trial using JCAR015 with cyclophosphamide pre-conditioning alone but in response to that request, the FDA said they need to see a revised patient informed consent form, a revised investigator brochure, and a revised trial protocol before deciding on whether to lift the hold.
JCAR015 is a chimeric antigen receptor T-Cell, or CAR-T, therapy, that is in development. According to Juno Therapeutics, the deaths in the current trial with JCAR015 do not impact other CAR-T therapies that Juno has in development.
Since the announcement, shares for Juno Therapeutics has dropped 30%.