Phase II trial investigates allogeneic CAR-T for large B-cell lymphoma

CAR-T for large B-cell lymphoma

Allogene Therapeutics and Foresight Diagnostics have announced the initiation of a Phase II trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line treatment regimen for newly diagnosed large B-cell lymphoma (LBCL) patients who are likely to relapse.

The ALPHA3 trial will screen patients who are likely to relapse after first line treatment for enrolment in the trial by using the Foresight Clarity Investigational Use Only (IUO) measurable residual disease (MRD) test.

Leveraging Clarity’s MRD technology, cema-cel will be administered as a one-time infusion immediately upon detection of MRD at the completion of six cycles of R-CHOP or another standard first line chemoimmunotherapy regimen.

When given as a seventh cycle of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve first line cure rates in LBCL.

Access to CAR-T in the community

“The transformative impact that the ALPHA3 trial could have on the treatment of first line LBCL is hard to overstate,” said David Chang, President, Chief Executive Officer and Co-Founder of Allogene. “Our investigational allogeneic CAR-T product is designed to eliminate the complex logistics that have hindered autologous CAR-T adoption to date and open the door for access by doctors in the community setting.”

The ALPHA3 trial will be conducted in a wide array of cancer treatment centres, including community cancer centres where most earlier line patients seek care.

This randomised study will enrol approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).

“Following the FDA Advisory Committee’s recent recommendation to include MRD as an endpoint to accelerate clinical trials in multiple myeloma, the ALPHA3 trial is yet another step forward towards broader implementation of MRD detection in drug development and clinical decision making,” said Dr Sandra Close, Chief Operating and Compliance Officer at Foresight Diagnostics.

Diana Spencer, Senior Digital Content Editor, DDW

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