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T cells
After 2 clinical holds in 2016 and 5 patient deaths, the Seattle biotech Juno Therapeutics is shutting down the phase 2 ROCKET trial of JCAR015.
The chimeric antigen receptor (CAR) T-cell therapy JCAR015 was being tested in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
“We have decided not to move forward . . . at this time,” CEO Hans Bishop said in a statement, “even though it generated important learnings for us and the immunotherapy field.”
He said the company remains “committed to developing better treatment for patients battling ALL.”
The first clinical hold of the ROCKET trial occurred in July after 2 patients died. The company attributed the deaths primarily to the addition of fludarabine to the regimen.
Juno removed fludarabine from the treatment protocol, the clinical hold was lifted, and the trial resumed.
Then, in November, 2 more patients died from cerebral edema, and the trial was put on hold once again.
One patient had died earlier in 2016, totaling 5 patient deaths from cerebral edema, although the earliest death was not necessarily related to treatment, the company stated.
Juno attributed the deaths to multiple factors, including the patients’ treatment history and treatment received at the beginning of the trial.
Juno plans to start a new adult ALL trial in 2018. The therapy, they say, is more similar to JCAR017, which is being tested in pediatric patients.
ROCKET is not the first trial of JCAR015 to be placed on hold.
In 2014, after 2 patients died of cytokine release syndrome, the phase 1 trial was placed on clinical hold.
Juno made changes to the enrollment criteria and dosing, and the hold was lifted. Results from this trial were presented at ASCO 2015 and ASCO 2016.
