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Juno Therapeutics places voluntary hold on CAR T-cell trial after patient deaths
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The phase 2 ROCKET trial designed to evaluate JCAR015 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia has been placed on voluntary clinical hold, according to the drug’s manufacturer.
JCAR015 (Juno Therapeutics) — a chimeric antigen receptor (CAR) T-cell product candidate — is designed to target CD19, identified on most B-cell malignancies, including various subtypes of non-Hodgkin lymphoma and ALL.
The hold was initiated after two patients suffered and died from cerebral edema earlier this week, according to a press release.
The same trial was previously halted after three patients died of cerebral edema after treatment with JCAR015. However, after fludarabine was replaced in the treatment regimen, the FDA removed the initial clinical hold and the study resumed in July.
The FDA has been notified of the voluntary hold.
Juno Therapeutics intends to work with the FDA and the Data and Safety Monitoring Board regarding its options for JCAR015, the release said.