Juno's CAR T-Cell Study Restarts, Without Fludarabine

Zosia Chustecka

July 14, 2016

The clinical trial of chimeric antigen receptor (CAR) T-cell therapy that was halted last week after two patients died has now been   restarted.

The trial, a phase 2 trial known as ROCKET, is being conducted by Juno Therapeutics with its anti-CD-19 CAR T-cell therapy, JCAR015, in adults with relapsed or refractory B-cell acute   lymphoblastic leukemia (ALL).

The two deaths in the trial occurred following the addition of fludarabine to the preconditioning regimen.

When the ROCKET trial began, preconditioning consisted of cyclophosphamide only, Hans Bishop, Juno's chief executive officer, said in a teleconference when the trial was halted. He explained   that fludarabine was added to the preconditioning regimen because previous studies had suggested greater efficacy.

"However, since adding fludarabine to the preconditioning on the ROCKET trial, we have seen an increase in the incidence of severe neurotoxicity, which unfortunately included two patient deaths   that occurred last week from cerebral edema that appeared to be treatment-related," Bishop said. There had been another death of a patient from cerebral edema earlier.

Juno has now announced that the Food and Drug Administration has lifted the clinical hold on the trial and that the trial will continue, using only   cyclophosphamide in the preconditioning regimen.

The JCAR015 product is based on patented technology developed at St. Jude Children's Research Hospital, for which Juno has an exclusive license.

The company hopes to file for approval of this product in 2017.

The CAR T-cell approach, which involves taking T-cells from patients, engineering them, and then reinfusing them back into the patient, has produced dramatic results in clinical trials in   leukemia and lymphoma patients, as previously reported by Medscape Medical News.


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