Novartis DLBCL CAR-T study closes recruitment amid enrollment backlog, faces long manufacturing wait times - source

05 Dec 2016

Novartis' (VTX:NOVN) Phase II JULIET study of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) is now closed for enrollment due to a large backlog of enrolled patients waiting to enter and receive treatment, a source said.

The 118-patient JULIET (NCT02445248) study opened in July 2015 and has an expected completion date of May 2022. While Kite Pharma's (NASDAQ:KITE) 124-patient Phase I/II ZUMA-1 study (NCT02348216) of KTE-C19 in aggressive non-Hodgkin's lymphomas (NHL), has had "reasonable" turnaround times of two- to three-week, the JULIET study's wait times for screening patients, manufacturing the tisagenlecleucel-T and getting it back to patients have been significantly longer, the source said. Consequently some patients have enrolled but not received treatment, the source said, though did not confirm when the study officially closed for enrollment.

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