azercabtagene zapreleucel (PBCAR0191)

P1/2, N=120, Recruiting, Imugene Limited

Azer-cel was administered as a single infusion to 44 subjects across several dose levels and fludarabine/cyclophosphamide lymphodepletion regimens. Post-thaw product composition and effective cell dose are predictive for in vivo expansion potential, CAR-T-related adverse events and response to treatment with azer-cel. This is the first analysis of an allogeneic CD19 CAR T product composition to demonstrate that strategies intended to maximize stem central memory T-cell fraction (CCR7+) while limiting CD4+ CCR7- differentiated fraction may improve safety and efficacy of CAR T therapy.

P1/2, N=120, Recruiting, Precision BioSciences, Inc. | N=92 --> 120 | Trial completion date: Jun 2022 --> Jun 2024 | Trial primary completion date: Feb 2022 --> Dec 2023

P1/2, N=92, Recruiting, Precision BioSciences, Inc. | Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Oct 2021 --> Feb 2022

P1/2, N=92, Recruiting, Precision BioSciences, Inc. | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jul 2020 --> Oct 2021

Lymphodepletion was administered on day -5 to day -3 using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day...One patient enrolled post disease progression after treatment with Axicabtagene ciloleucel... Further enrollment of patients into DL2 is ongoing. Data from DL2 entered by early October will be included in a presentation in the meeting. Findings to date indicate preliminary evidence of short-lived cell-mediated anti-tumor effect and preliminary evidence of cell expansion in vivo, which will be evaluated more fully at DL2 and DL3.