{"id":43902,"date":"2025-10-20T20:03:09","date_gmt":"2025-10-20T12:03:09","guid":{"rendered":"https:\/\/flcube.com\/?p=43902"},"modified":"2025-10-20T20:03:10","modified_gmt":"2025-10-20T12:03:10","slug":"carsgen-announces-promising-phase-ib-results-for-satricabtagene-autoleucel-injection-in-post%e2%80%91surgery-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43902","title":{"rendered":"CARsgen Announces Promising Phase\u202fIb Results for Satricabtagene Autoleucel Injection in Post\u2011Surgery Pancreatic Cancer"},"content":{"rendered":"\n<p><strong>CARsgen Therapeutics Holdings Limited (<a href=\"https:\/\/www.google.com\/finance\/quote\/2171:HKG\">HKG: 2171<\/a>)<\/strong> today disclosed interim data from the Phase\u202fIb registrational study <strong>CT041\u2011ST\u201105 (NCT05911217)<\/strong> of <strong>Satricabtagene Autoleucel Injection (CT041)<\/strong> presented at the <strong>European Society for Medical Oncology (ESMO) Congress\u202f2025<\/strong>. The trial evaluated the adjuvant efficacy of this autologous CAR\u2011T cell therapy in <strong>Claudin\u201118.2\u2011positive pancreatic ductal adenocarcinoma (PDAC)<\/strong> patients who had undergone curative resection, completed adjuvant chemotherapy, and remained disease\u2011free at baseline.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trial-design-amp-patient-population\">Trial Design &amp; Patient Population<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Enrollment<\/strong> \u2013 6 PDAC subjects (Claudin\u201118.2\u202f+\u202f, abnormal CA19\u20119, \u2265\u202f3\u202fmonths adjuvant chemo, no recurrence).<\/li>\n\n\n\n<li><strong>Study Period<\/strong> \u2013 15\u202fSep\u202f2023 to 11\u202fApr\u202f2025 (data cutoff).<\/li>\n\n\n\n<li><strong>Intervention<\/strong> \u2013 Single infusion of Satricabtagene Autoleucel Injection, followed by \u2265\u202f4\u202fweeks of follow\u2011up.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-clinical-outcomes\">Key Clinical Outcomes<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result<\/th><\/tr><\/thead><tbody><tr><td><strong>Disease\u2011Free Survival (DFS)<\/strong><\/td><td>Median not reached; 9\u2011month DFS rate <strong>83.3\u202f%<\/strong><\/td><\/tr><tr><td><strong>Overall Survival (OS)<\/strong><\/td><td>Median not reached<\/td><\/tr><tr><td><strong>Disease Recurrence<\/strong><\/td><td>1\/6 patients (16.7\u202f%) recurred; 5\/6 remained disease\u2011free<\/td><\/tr><tr><td><strong>CA19\u20119 Decline<\/strong><\/td><td>5\/6 patients (83.3\u202f%) showed \u2265\u202f51.3\u202f% reduction (range 51.3\u201196.1\u202f%)<\/td><\/tr><tr><td><strong>Long\u2011Term Follow\u2011Up<\/strong><\/td><td>1 patient completed 52\u202fweeks post\u2011infusion with no recurrence<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Safety<\/strong> \u2013 No treatment\u2011related serious adverse events reported in the 6\u2011patient cohort.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-milestones\">Development Milestones<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>June\u202f25\u202f2025<\/strong> \u2013 China\u2019s National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for Satricabtagene Autoleucel Injection in <strong>Claudin\u201118.2\u2011positive advanced gastric\/gastroesophageal junction adenocarcinoma (GC\/GEJC)<\/strong> patients refractory to \u2265\u202f2 prior lines of therapy.<\/li>\n\n\n\n<li><strong>Strategic Positioning<\/strong> \u2013 Satricabtagene Autoleucel is the first\u2011in\u2011class autologous CAR\u2011T targeting Claudin\u201118.2, with potential applicability across Claudin\u201118.2\u2011positive solid tumors.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CARsgen Therapeutics Holdings Limited (HKG: 2171) today disclosed interim data from the Phase\u202fIb registrational study&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43903,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[106,16,21,379,77,1188],"class_list":["post-43902","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-cancer","tag-car-t","tag-carsgen-therapeutics","tag-cell-therapy","tag-hkg-2171"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CARsgen Announces Promising Phase\u202fIb Results for Satricabtagene Autoleucel Injection in Post\u2011Surgery Pancreatic Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"CARsgen Therapeutics Holdings Limited (HKG: 2171) today disclosed interim data from the Phase\u202fIb registrational study CT041\u2011ST\u201105 (NCT05911217) of Satricabtagene Autoleucel Injection (CT041) presented at the European Society for Medical Oncology (ESMO) Congress\u202f2025. The trial evaluated the adjuvant efficacy of this autologous CAR\u2011T cell therapy in Claudin\u201118.2\u2011positive pancreatic ductal adenocarcinoma (PDAC) patients who had undergone curative resection, completed adjuvant chemotherapy, and remained disease\u2011free at baseline.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=43902\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CARsgen Announces Promising Phase\u202fIb Results for Satricabtagene Autoleucel Injection in Post\u2011Surgery Pancreatic Cancer\" \/>\n<meta property=\"og:description\" content=\"CARsgen Therapeutics Holdings Limited (HKG: 2171) today disclosed interim data from the Phase\u202fIb registrational study CT041\u2011ST\u201105 (NCT05911217) of Satricabtagene Autoleucel Injection (CT041) presented at the European Society for Medical Oncology (ESMO) Congress\u202f2025. 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