{"id":953314,"date":"2026-04-21T08:34:18","date_gmt":"2026-04-21T12:34:18","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/allogene-therapeutics-expands-pivotal-phase-2-alpha3-trial-to-south-korea-and-australia\/"},"modified":"2026-04-21T08:34:18","modified_gmt":"2026-04-21T12:34:18","slug":"allogene-therapeutics-expands-pivotal-phase-2-alpha3-trial-to-south-korea-and-australia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/allogene-therapeutics-expands-pivotal-phase-2-alpha3-trial-to-south-korea-and-australia\/","title":{"rendered":"Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>Expansion Adds to Growing Global Trial Footprint<\/li>\n<li>Patient Screening and Enrollment Expected to Begin in Q2 2026<\/li>\n<\/ul>\n<p>SOUTH SAN FRANCISCO, Calif., April  21, 2026  (GLOBE NEWSWIRE) &#8212; 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, today announced that regulatory authorities in South Korea and Australia have cleared the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL).<\/p>\n<p>The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. This growing trial footprint reflects strong interest in ALPHA3 from clinical trial sites.<\/p>\n<p>\u201cExpanding into South Korea and Australia allows us to leverage regions with established clinical research infrastructure and experienced investigators,\u201d said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. \u201cThese countries provide high-quality trial environments and efficient healthcare delivery systems. These regulatory approvals, follow our recent interim futility analysis, and we expect this expansion to support the continued enrollment and global development of cema-cel.\u201d<\/p>\n<p>The Company recently announced findings from a planned interim futility analysis of the ALPHA3 trial from the first 24 patients enrolled. In this analysis, cema-cel demonstrated a 58.3% (7\/12) minimal residual disease (MRD) clearance versus 16.7% (2\/12) in the standard-of-care (SOC) observation arm in the 1L consolidation setting. Cema-cel was generally well-tolerated, with no serious treatment-related adverse events and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). There were no hospitalizations for treatment-related adverse events, suggesting consolidation of MRD+ remission with cema-cel may be suitable for a fully outpatient regimen. The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028. If positive, results could support a Biologics License Application (BLA) submission.<\/p>\n<p><strong>About Cemacabtagene Ansegedleucel (cema-cel)<\/strong><br \/>Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T\u00a0investigational product for the treatment of large B cell lymphoma (LBCL). In\u00a0June 2022, the\u00a0U.S. Food and Drug Administration\u00a0granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r\/r LBCL. Allogene has oncology rights to cema-cel in the US, EU and\u00a0UK\u00a0with options for rights in\u00a0China\u00a0and\u00a0Japan.<\/p>\n<p><strong>About the ALPHA3 Trial<\/strong><br \/>Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the\u00a0UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to \u201cwatch and wait\u201d 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 \u201c7th cycle\u201d of frontline treatment available to all eligible patients with MRD.<\/p>\n<p>\n        <strong>About Allogene Therapeutics<\/strong><br \/>\n        <br \/>Allogene Therapeutics, with headquarters in\u00a0South San Francisco, is a clinical-stage\u00a0biotechnology company pioneering the development of allogeneic chimeric antigen receptor T\u00a0cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant\u00a0experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell product\u00a0candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at\u00a0greater scale to more patients. For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=wjFlPAfG0ik-Yx2vPAlIXbDkR8QUz1h_5n-Xh6aMaOTG0cjpjWR6K0q63lvSDuP9nBWIebDepPKSes-bm9OCM8spY0kXCokdd0Rt4WHVuXI=\" rel=\"nofollow\" target=\"_blank\">www.allogene.com<\/a>, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.<\/p>\n<p>\n        <strong>Cautionary Note on Forward-Looking Statements for Allogene<\/strong><br \/>\n        <br \/>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on management\u2019s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In some cases, forward-looking statements may be identified by words such as \u201canticipate,\u201d \u201cexpect,\u201d \u201cbelieve,\u201d \u201caim,\u201d \u201cplan,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201cestimate,\u201d \u201ctarget,\u201d \u201cpotential,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201cdesigned to,\u201d \u201csuggest,\u201d \u201cpossible,\u201d and similar expressions. Forward-looking statements in this press release include, but are not limited to, statements regarding the ongoing Phase 2 ALPHA3 trial of cema-cel, including geographic expansion of the trial, anticipated site activations, and the completion thereof and the timing for data announcements; the potential clinical benefits, safety, tolerability, durability, and efficacy of cema-cel, including its potential to enable earlier intervention in LBCL; its favorable safety profile, and its potential for rapid availability, operational simplicity and outpatient use; the interim futility analysis data providing initial support to suggest that cema-cel may offer a new strategy to treat high-risk patients at the end of first-line treatment; the potential for MRD-guided first-line consolidation to improve outcomes in LBCL, including the potential to eliminate residual disease, and potentially prevent recurrence; the participation from community cancer centers in the Phase 2 ALPHA3 trial underscoring the ability to offer cema-cel in community settings and supporting the potential for broader adoption; and Allogene\u2019s ability to develop and deliver readily available allogeneic CAR T products for the treatment of cancer and autoimmune disease on-demand, more reliably, and at greater scale to more patients. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, but not limited to, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results and data from a small sample size may not be indicative of results that may be observed in a larger group), patient enrollment and trial execution risks, including risks related to activating and conducting clinical trial sites in additional jurisdictions, uncertainties related to MRD testing and its clinical significance and reliability, including whether MRD is predictor of relapse in LBCL or MRD clearance improvements translate to meaningful clinical benefits, the occurrence of adverse safety events, regulatory risks and uncertainties, manufacturing and CMC risks, reliance on third parties and licensors, competitive developments, intellectual property and contractual risks, and financial risks, including the need for additional capital. These and other risks and uncertainties are described more fully in Allogene\u2019s filings with the Securities and Exchange Commission (SEC), including under the heading \u201cRisk Factors\u201d in its most recent Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, and other filings that Allogene may make from time to time with the SEC. All forward-looking statements in this press release speak only as of the date of this press release, and Allogene undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.<\/p>\n<p>Allogene\u2019s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom.<\/p>\n<p>\n        <strong>Allogene Media\/Investor Contact:<\/strong><br \/>\n        <br \/>Christine Cassiano<br \/>EVP, Chief Corporate Affairs &amp; Brand Strategy Officer<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=B4zYeQTQ7My78uAsZSt_-QPNg0s1xUGGTTyWmnCv37afT3lZeFUbYYkbshFjNR-AOm5SNjY65n9QEqiEuE-stiD3R1m0OFfD785iOJxqB4tbIbDqXTQ5ypsgZCru9YAz\" rel=\"nofollow\" target=\"_blank\">Christine.Cassiano@allogene.com<\/a><\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY5MzcyMSM3NTQ2NjM1IzIxMjQyNDc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/Yjc4OGQwZjUtZDkwZi00OWIxLTgzMjQtOWJiYzFmMmExYjVhLTExMzU4MTgtMjAyNi0wNC0yMS1lbg==\/tiny\/Allogene-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Expansion Adds to Growing Global Trial Footprint Patient Screening and Enrollment Expected to Begin in Q2 2026 SOUTH SAN FRANCISCO, Calif., April 21, 2026 (GLOBE NEWSWIRE) &#8212; 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, today announced that regulatory authorities in South Korea and Australia have cleared the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. This growing trial footprint &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/allogene-therapeutics-expands-pivotal-phase-2-alpha3-trial-to-south-korea-and-australia\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-953314","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/allogene-therapeutics-expands-pivotal-phase-2-alpha3-trial-to-south-korea-and-australia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Expansion Adds to Growing Global Trial Footprint Patient Screening and Enrollment Expected to Begin in Q2 2026 SOUTH SAN FRANCISCO, Calif., April 21, 2026 (GLOBE NEWSWIRE) &#8212; 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, today announced that regulatory authorities in South Korea and Australia have cleared the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. 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(Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced that regulatory authorities in South Korea and Australia have cleared the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. 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