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Juno Therapeutics halts development of JCAR015 for ALL
Juno Therapeutics ceased development of JCAR015, an experimental chimeric antigen receptor–modified T-cell therapy.
In July, the FDA placed a clinical hold on the phase 2 ROCKET study — designed to evaluate the therapy in adults with relapsed or refractory B-cell acute lymphoblastic leukemia — after three patients died of cerebral edema.
The FDA removed the clinical hold after fludarabine was replaced in the treatment regimen, and the study resumed a short time later.
In November, Juno Therapeutics placed a voluntary clinical hold on the trial after two more patients died of cerebral edema.
“We have decided not to move forward with the ROCKET trial or JCAR015 at this time, even though it generated important learnings for us and the immunotherapy field,” Hans Bishop, president and CEO of Juno Therapeutics, said in a company-issued press release. “We remain committed to developing better treatments for patients battling ALL and believe an approach using our defined cell technology is the best platform to pursue.
“We intend to begin a trial with a defined cell product candidate in adult ALL next year,” Bishop added. “We look forward to sharing detailed data supporting our learnings from the ROCKET trial at an upcoming scientific conference.”