On November 3, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that a Trial-in-Progress (TIP) poster highlighting the pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) will be presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida.
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ALPHA3 is a randomized study with two arms, comparing cema-cel administered following standard FC lymphodepletion versus observation, the current standard of care. The poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cema-cel as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy.
Cema-cel is an investigational, next-generation anti-CD19 AlloCAR T product designed to provide an "off-the-shelf" cell therapy option that can be administered immediately upon the detection of MRD. With its focus on this rapidly emerging area in oncology, the ALPHA3 trial positions Allogene at the forefront of a transformative shift toward earlier and more precise treatment. A futility analysis comparing MRD conversion between the two arms is expected to occur 1H 2026.
Poster Presentation Details:
ALPHA3: First-line consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy: the pivotal, randomized, open-label phase 2 ALPHA3 study
Presenter: John Burke, MD, Blood Cancer Specialist, Rocky Mountain Cancer Centers
Publication Number: 3730
Location: West Halls B3-B4: Orange County Convention Center (OCCC), Orlando, FL
Session Name: 628. Aggressive Lymphomas: Cellular Therapies: Poster II
Poster Session Display Date and Time: Sunday, December 7, 6:00PM-8:00PM ET
About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.
About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.
(Press release, Allogene, NOV 3, 2025, View Source [SID1234659239])