NEW YORK – Allogene Therapeutics and Foresight Diagnostics on Thursday said they will partner to develop an in vitro diagnostic test to select patients with minimal residual disease (MRD) after first-line consolidation therapy for a Phase II clinical trial of its anti-CD19 CAR T-cell therapy cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL).
San Francisco-based Allogene is currently studying cema-cel (formerly ALLO-501A) with its anti-CD52 monoclonal antibody ALLO-647 in a Phase I/II trial, dubbed ALPHA2, as a treatment for patients with relapsed or refractory LBCL after a standard lymphodepletion therapy regimen. In results from the trial that were reported in June 2023, seven of 12 patients, or 58 percent, receiving the Phase II therapy regimen achieved a complete response, and five out of 12, or 42 percent, had a complete response at six months after beginning treatment. The median duration of response was 23.1 months.
The firms now plan to use Foresight’s PhasED-Seq ctDNA-MRD platform to identify patients with MRD in a new Phase II trial, ALPHA3, which is expected to begin in mid-2024. In this study, researchers will evaluate the potential benefits of cema-cel as a consolidation therapy for patients with newly diagnosed LBCL who are at high risk of recurrence.
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