BioCentury
ARTICLE | Product Development

ROCKET resumes

Pondering reasons for neurotoxicity in Juno's CAR T leukemia trial

July 18, 2016 7:00 AM UTC

The swift release of a clinical hold on Juno Therapeutics Inc.'s ROCKET trial notwithstanding, why and how high-dose fludarabine contributed to fatal neurotoxicity remains an unanswered - and important - question for the CAR T field.

FDA appears to agree with the company that the addition of fludarabine to the conditioning regimen used in ROCKET was the culprit in the deaths of three patients with acute lymphoblastic leukemia (ALL) who received JCAR015. And Juno has hypothesized that fludarabine and JCAR015 may have acted synergistically to unleash a rapid expansion of T cells in the CNS...