Trial Profile

Pivotal trial of Azercabtagene-zapreleucel (Azer-Cel) in LBCL

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 04 Sep 2024

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At a glance

03 Sep 2024 The company will continue to enroll additional patients in Cohort B from Phase 1b Trial and follow patients for durability of response with the goal of providing a comprehensive package to the FDA for the potential Phase 2/3 registrational trial.
03 Sep 2024 According to an Imugene media release, Cohort B regimen (azer-cel, lymphodepletion (chemotherapy)1, and interleukin 2 (IL-2)) is planned to be included in the potential Registrational FDA Phase 2/3 package.
22 Feb 2024 According to an Imugene media release, positive FDA guidance has received on this potential registrational study, which could start after completion of the confirmation study.

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