{"success":true,"data":{"pressRelease":{"id":"179009","rtpr_id":"nPn8T5Nz5a-20261026","ticker":"2171","exchange":"HKEX","all_tickers":["2171"],"title":"Results of CARsgen's Satri-cel for Adjuvant Treatment for Gastric Cancer Presented at ESMO Congress 2026","author":"PR Newswire","published_at":"2026-10-26T00:30:00.239Z","article_body":"Results of CARsgen's Satri-cel for Adjuvant Treatment for Gastric Cancer Presented at ESMO Congress 2026\nPR Newswire\n\nSHANGHAI, Oct. 25, 2026\n\nSHANGHAI, Oct. 25, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited\n(Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell\ntherapies, announces that the preliminary positive research results of the\ninvestigator-initiated trial (CT041-CG4010, NCT06857786) in China of\nsatricabtagene autoleucel (\"satri-cel\", CT041) (an autologous CAR T-cell\nproduct against Claudin18.2), as consolidation therapy following adjuvant\ntreatment for locally advanced gastric or gastroesophageal junction cancer,\nhave been presented in a poster session at the European Society for Medical\nOncology (ESMO) Congress 2026 (Poster number: 1056P)([1]).\n\nPrognosis remains suboptimal in high-risk patients with locally advanced\ngastric cancer who have undergone curative gastrectomy, with a 1-year\ndisease-free survival (DFS) rate of only about 73–78%, while the 2-year DFS\nrate further declines to 58–64%([2]), underscoring the urgent need for novel\ntherapeutic strategies. The CT041-CG4010 trial represents an important attempt\nworldwide to explore CAR T-cell therapy for post-surgical adjuvant treatment\nof gastric cancer. This trial enrolled locally advanced\ngastric/gastroesophageal junction adenocarcinoma (G/GEJC) patients who had\nundergone radical gastrectomy with D2 lymphadenectomy, with pathologically\nconfirmed (y)pT4aN+ or T4bNany disease. The primary endpoint was safety, and\nsecondary endpoints included efficacy and pharmacokinetics.\n\nAccording to the study results, up to the data cut-off date (September 14,\n2026), 10 patients received satri-cel infusion. All patients had pathological\nstage T4a or T4b with node-positive disease, of whom up to 80% had N2/N3 stage\n(60% N3). Lauren diffuse type accounted for 90% of patients and signet-ring\ncell carcinoma for 70%, collectively indicating a patient population at\nextremely high risk of postoperative recurrence.\n\nSeven patients had completed at least 12 months of postoperative follow-up, of\nwhom five patients completed M18 post-surgery follow-up, including 2 patients\nwho completed M21 follow-up. None of the infused patients experienced\npostoperative recurrence or metastasis of gastric cancer; the 12-month (M12)\nDFS rate was 100% and the median DFS was not reached. One patient was minimal\nresidual disease (MRD)-positive by circulating tumor DNA (ctDNA) before\ninfusion, which turned negative at the first assessment after satri-cel\ninfusion, and remained negative during subsequent follow-up. In terms of\npharmacokinetics, all patients showed solid CAR T expansion.\n\nAs for safety, the incidence of cytokine release syndrome (CRS) was 80%, and\nall events were grade 1–2, with a median time to recovery of 4 days. No\nimmune effector cell-associated neurotoxicity syndrome (ICANS) occurred, and\nno adverse events leading to death were reported. The overall safety profile\nwas manageable.\n\nDr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and\nChief Scientific Officer of CARsgen, stated, \"We are pleased to see that\nsatri-cel has shown encouraging preliminary results in the novel exploratory\nsetting of adjuvant therapy following gastrectomy. For patients with locally\nadvanced gastric cancer at high risk of postoperative recurrence, the benefit\nof existing adjuvant therapies remains limited. In this study, none of the\npatients have experienced recurrence to date, the 12-month DFS rate reached\n100%, and one patient's MRD converted from positive to negative. These\nfindings suggest that satri-cel may clear minimal residual disease and\npotentially alter the disease course for these patients, with a more favorable\nsafety profile than in the later-line setting and overall manageable. Building\non the approval of satri-cel for later-line treatment of advanced gastric\ncancer, we will continue to advance its exploration into earlier-line settings\nsuch as post-surgical adjuvant therapy and sequential therapy following\nfirst-line treatment, with the goal of providing better curative opportunities\nfor a broader patient population.\"\n\nAbout Satri-cel\nSatri-cel is an autologous CAR T-cell therapy product against the protein\nClaudin18.2 that is the first-in-class globally. Satri-cel targets the\ntreatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in\nJune 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced\ngastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have\nfailed at least two prior lines of therapy, making it the world's first\napproved CAR T-cell therapy product for solid tumors.\n\nThe Company is actively expanding satri-cel application in early-line\ntreatment and perioperative treatment of cancer, including an ongoing Phase I\nclinical trial for pancreatic cancer adjuvant therapy in China (NCT05911217),\nan IIT for consolidation treatment following adjuvant therapy in patients with\nresected G/GEJA (NCT06857786) and an IIT for sequential therapy following\nfirst-line treatment for G/GEJA (NCT07179484).\n\nAbout CARsgen Therapeutics Holdings Limited\nCARsgen is a biopharmaceutical company focusing on developing innovative CAR\nT-cell therapies to address the unmet clinical needs including but not limited\nto hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has\nestablished end-to-end capabilities for CAR T-cell research and development\ncovering target discovery, preclinical research, product clinical development,\nand commercial-scale production. CARsgen has developed novel in-house\ntechnologies and a product pipeline with global rights to address challenges\nfaced by existing CAR T-cell therapies. Efforts include improving safety\nprofile, enhancing the efficacy in treating solid tumors, and reducing\ntreatment costs, etc. CARsgen's mission is to be a global biopharmaceutical\nleader that provides innovative and differentiated cell therapies for patients\nworldwide and makes cancer and other diseases curable.\n\nForward-looking Statements\nAll statements in this press release that are not historical fact or that do\nnot relate to present facts or current conditions are forward-looking\nstatements. Such forward-looking statements express the Group's current views,\nprojections, beliefs and expectations with respect to future events as of the\ndate of this press release. Such forward-looking statements are based on a\nnumber of assumptions and factors beyond the Group's control. As a result,\nthey are subject to significant risks and uncertainties, and actual events or\nresults may differ materially from these forward-looking statements and the\nforward-looking events discussed in this press release might not occur. Such\nrisks and uncertainties include, but are not limited to, those detailed under\nthe heading \"Principal Risks and Uncertainties\" in our most recent annual\nreport and interim report and other announcements and reports made available\non our corporate website, https://www.carsgen.com (https://www.carsgen.com/) .\nNo representation or warranty is given as to the achievement or reasonableness\nof, and no reliance should be placed on, any projections, targets, estimates\nor forecasts contained in this press release.\n\nReferences\n [1] Qi C, et al. ESMO 2026. Poster #1056P.\n [2] Zhang X, et al. Lancet Oncol. 2025 Mar;26(3):312-319.\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/results-of-carsgens-satri-cel-for-adjuvant-treatment-for-gastric-cancer-presented-at-esmo-congress-2026-302917974.html\n(https://www.prnewswire.com/news-releases/results-of-carsgens-satri-cel-for-adjuvant-treatment-for-gastric-cancer-presented-at-esmo-congress-2026-302917974.html)\n\nSOURCE CARsgen Therapeutics\n\n\n\nContact CARsgen: For more information, please visit https://www.carsgen.com/; Public Relations: PR@carsgen.com; Investor Relations: IR@carsgen.com\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1320427/Logo.jpg?id=OA3036330\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn8T5Nz5a-20261026","title":"Results of CARsgen's Satri-cel for Adjuvant Treatment for Gastric Cancer Presented at ESMO Congress 2026","author":"PR Newswire","ticker":"2171","created":"2026-10-26T00:30:00.239Z","tickers":["2171"],"exchange":"HKEX","article_body":"Results of CARsgen's Satri-cel for Adjuvant Treatment for Gastric Cancer Presented at ESMO Congress 2026\nPR Newswire\n\nSHANGHAI, Oct. 25, 2026\n\nSHANGHAI, Oct. 25, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited\n(Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell\ntherapies, announces that the preliminary positive research results of the\ninvestigator-initiated trial (CT041-CG4010, NCT06857786) in China of\nsatricabtagene autoleucel (\"satri-cel\", CT041) (an autologous CAR T-cell\nproduct against Claudin18.2), as consolidation therapy following adjuvant\ntreatment for locally advanced gastric or gastroesophageal junction cancer,\nhave been presented in a poster session at the European Society for Medical\nOncology (ESMO) Congress 2026 (Poster number: 1056P)([1]).\n\nPrognosis remains suboptimal in high-risk patients with locally advanced\ngastric cancer who have undergone curative gastrectomy, with a 1-year\ndisease-free survival (DFS) rate of only about 73–78%, while the 2-year DFS\nrate further declines to 58–64%([2]), underscoring the urgent need for novel\ntherapeutic strategies. The CT041-CG4010 trial represents an important attempt\nworldwide to explore CAR T-cell therapy for post-surgical adjuvant treatment\nof gastric cancer. This trial enrolled locally advanced\ngastric/gastroesophageal junction adenocarcinoma (G/GEJC) patients who had\nundergone radical gastrectomy with D2 lymphadenectomy, with pathologically\nconfirmed (y)pT4aN+ or T4bNany disease. The primary endpoint was safety, and\nsecondary endpoints included efficacy and pharmacokinetics.\n\nAccording to the study results, up to the data cut-off date (September 14,\n2026), 10 patients received satri-cel infusion. All patients had pathological\nstage T4a or T4b with node-positive disease, of whom up to 80% had N2/N3 stage\n(60% N3). Lauren diffuse type accounted for 90% of patients and signet-ring\ncell carcinoma for 70%, collectively indicating a patient population at\nextremely high risk of postoperative recurrence.\n\nSeven patients had completed at least 12 months of postoperative follow-up, of\nwhom five patients completed M18 post-surgery follow-up, including 2 patients\nwho completed M21 follow-up. None of the infused patients experienced\npostoperative recurrence or metastasis of gastric cancer; the 12-month (M12)\nDFS rate was 100% and the median DFS was not reached. One patient was minimal\nresidual disease (MRD)-positive by circulating tumor DNA (ctDNA) before\ninfusion, which turned negative at the first assessment after satri-cel\ninfusion, and remained negative during subsequent follow-up. In terms of\npharmacokinetics, all patients showed solid CAR T expansion.\n\nAs for safety, the incidence of cytokine release syndrome (CRS) was 80%, and\nall events were grade 1–2, with a median time to recovery of 4 days. No\nimmune effector cell-associated neurotoxicity syndrome (ICANS) occurred, and\nno adverse events leading to death were reported. The overall safety profile\nwas manageable.\n\nDr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and\nChief Scientific Officer of CARsgen, stated, \"We are pleased to see that\nsatri-cel has shown encouraging preliminary results in the novel exploratory\nsetting of adjuvant therapy following gastrectomy. For patients with locally\nadvanced gastric cancer at high risk of postoperative recurrence, the benefit\nof existing adjuvant therapies remains limited. In this study, none of the\npatients have experienced recurrence to date, the 12-month DFS rate reached\n100%, and one patient's MRD converted from positive to negative. These\nfindings suggest that satri-cel may clear minimal residual disease and\npotentially alter the disease course for these patients, with a more favorable\nsafety profile than in the later-line setting and overall manageable. Building\non the approval of satri-cel for later-line treatment of advanced gastric\ncancer, we will continue to advance its exploration into earlier-line settings\nsuch as post-surgical adjuvant therapy and sequential therapy following\nfirst-line treatment, with the goal of providing better curative opportunities\nfor a broader patient population.\"\n\nAbout Satri-cel\nSatri-cel is an autologous CAR T-cell therapy product against the protein\nClaudin18.2 that is the first-in-class globally. Satri-cel targets the\ntreatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in\nJune 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced\ngastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have\nfailed at least two prior lines of therapy, making it the world's first\napproved CAR T-cell therapy product for solid tumors.\n\nThe Company is actively expanding satri-cel application in early-line\ntreatment and perioperative treatment of cancer, including an ongoing Phase I\nclinical trial for pancreatic cancer adjuvant therapy in China (NCT05911217),\nan IIT for consolidation treatment following adjuvant therapy in patients with\nresected G/GEJA (NCT06857786) and an IIT for sequential therapy following\nfirst-line treatment for G/GEJA (NCT07179484).\n\nAbout CARsgen Therapeutics Holdings Limited\nCARsgen is a biopharmaceutical company focusing on developing innovative CAR\nT-cell therapies to address the unmet clinical needs including but not limited\nto hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has\nestablished end-to-end capabilities for CAR T-cell research and development\ncovering target discovery, preclinical research, product clinical development,\nand commercial-scale production. CARsgen has developed novel in-house\ntechnologies and a product pipeline with global rights to address challenges\nfaced by existing CAR T-cell therapies. Efforts include improving safety\nprofile, enhancing the efficacy in treating solid tumors, and reducing\ntreatment costs, etc. CARsgen's mission is to be a global biopharmaceutical\nleader that provides innovative and differentiated cell therapies for patients\nworldwide and makes cancer and other diseases curable.\n\nForward-looking Statements\nAll statements in this press release that are not historical fact or that do\nnot relate to present facts or current conditions are forward-looking\nstatements. Such forward-looking statements express the Group's current views,\nprojections, beliefs and expectations with respect to future events as of the\ndate of this press release. Such forward-looking statements are based on a\nnumber of assumptions and factors beyond the Group's control. As a result,\nthey are subject to significant risks and uncertainties, and actual events or\nresults may differ materially from these forward-looking statements and the\nforward-looking events discussed in this press release might not occur. Such\nrisks and uncertainties include, but are not limited to, those detailed under\nthe heading \"Principal Risks and Uncertainties\" in our most recent annual\nreport and interim report and other announcements and reports made available\non our corporate website, https://www.carsgen.com (https://www.carsgen.com/) .\nNo representation or warranty is given as to the achievement or reasonableness\nof, and no reliance should be placed on, any projections, targets, estimates\nor forecasts contained in this press release.\n\nReferences\n [1] Qi C, et al. ESMO 2026. Poster #1056P.\n [2] Zhang X, et al. Lancet Oncol. 2025 Mar;26(3):312-319.\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/results-of-carsgens-satri-cel-for-adjuvant-treatment-for-gastric-cancer-presented-at-esmo-congress-2026-302917974.html\n(https://www.prnewswire.com/news-releases/results-of-carsgens-satri-cel-for-adjuvant-treatment-for-gastric-cancer-presented-at-esmo-congress-2026-302917974.html)\n\nSOURCE CARsgen Therapeutics\n\n\n\nContact CARsgen: For more information, please visit https://www.carsgen.com/; Public Relations: PR@carsgen.com; Investor Relations: IR@carsgen.com\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1320427/Logo.jpg?id=OA3036330\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-26T00:30:00.275921968Z","server_sent_at_ms":1792974600275},"received_at":"2026-10-26T00:30:00.334Z","source_url":"https://www.prnewswire.com/news-releases/results-of-carsgens-satri-cel-for-adjuvant-treatment-for-gastric-cancer-presented-at-esmo-congress-2026-302917974.html"},"analysis":{"id":"166906","press_release_id":"179009","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["Very small sample size (10 patients, only 7 with 12+ months follow-up) from an investigator-initiated trial; results are preliminary and not randomized"],"eventType":"clinical_trial","narrative":"CARsgen presented preliminary positive results of satri-cel (CT041) as post-surgical adjuvant consolidation therapy for locally advanced gastric/gastroesophageal junction cancer in a poster at the ESMO Congress 2026.\n\nIn the 10-patient investigator-initiated trial, no patient experienced recurrence or metastasis, the 12-month disease-free survival rate was 100% versus a historical benchmark of 73-78%, and one patient's MRD turned ctDNA-negative after infusion. Safety was manageable with only grade 1-2 cytokine release syndrome (80% incidence, 4-day median recovery) and no ICANS or deaths.\n\nThe data support CARsgen's strategy of moving satri-cel, already NMPA-approved for later-line advanced gastric cancer, into earlier-line and perioperative settings including adjuvant therapy and post-first-line sequential therapy.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"100% 12-month DFS in first-ever CAR T adjuvant gastric cancer study positions satri-cel for earlier-line expansion."},"keyFigures":{"drugName":"satri-cel (satricabtagene autoleucel, CT041)","phaseOfTrial":"investigator-initiated trial (CT041-CG4010)","customDimensions":{"crs_incidence":"80%","crs_max_grade":"grade 1-2","patients_infused":10,"dfs_12_month_rate":"100%","historical_1yr_dfs_benchmark":"73-78%","historical_2yr_dfs_benchmark":"58-64%"}},"quotedText":"These findings suggest that satri-cel may clear minimal residual disease and potentially alter the disease course for these patients, with a more favorable safety profile than in the later-line setting and overall manageable.","namedEntities":{"people":[{"name":"Dr. Zonghai Li","role":"Founder, Chairman, CEO and Chief Scientific Officer of CARsgen"}],"products":["satri-cel","satricabtagene autoleucel","CT041"],"companies":[{"name":"CARsgen Therapeutics Holdings Limited","ticker":"2171.HK","relationship":"filer"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference organizer"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive preliminary data for satri-cel as adjuvant therapy in gastric cancer: 100% 12-month DFS in 10 high-risk patients with no recurrences and manageable safety. Small investigator-initiated trial (n=10), so promising but early-stage evidence supporting expansion into earlier-line settings."},"tickerRelevance":{"others":[],"primary":"2171"},"globalImportance":32,"audienceRelevance":22,"eventTypeSecondary":[],"importanceComponents":{"sampleSize":"n=10, preliminary","tickerTier":"small-cap HK-listed biotech","eventGravity":"positive early-stage clinical data at major congress","strategicSignificance":"first-in-class solid tumor CAR T moving into adjuvant setting"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"CARsgen presented preliminary positive results of satri-cel (CT041) as post-surgical adjuvant consolidation therapy for locally advanced gastric/gastroesophageal junction cancer in a poster at the ESMO Congress 2026.\n\nIn the 10-patient investigator-initiated trial, no patient experienced recurrence or metastasis, the 12-month disease-free survival rate was 100% versus a historical benchmark of 73-78%, and one patient's MRD turned ctDNA-negative after infusion. Safety was manageable with only grade 1-2 cytokine release syndrome (80% incidence, 4-day median recovery) and no ICANS or deaths.\n\nThe data support CARsgen's strategy of moving satri-cel, already NMPA-approved for later-line advanced gastric cancer, into earlier-line and perioperative settings including adjuvant therapy and post-first-line sequential therapy.","key_figures":{"drugName":"satri-cel (satricabtagene autoleucel, CT041)","phaseOfTrial":"investigator-initiated trial (CT041-CG4010)","customDimensions":{"crs_incidence":"80%","crs_max_grade":"grade 1-2","patients_infused":10,"dfs_12_month_rate":"100%","historical_1yr_dfs_benchmark":"73-78%","historical_2yr_dfs_benchmark":"58-64%"}},"named_entities":{"people":[{"name":"Dr. Zonghai Li","role":"Founder, Chairman, CEO and Chief Scientific Officer of CARsgen"}],"products":["satri-cel","satricabtagene autoleucel","CT041"],"companies":[{"name":"CARsgen Therapeutics Holdings Limited","ticker":"2171.HK","relationship":"filer"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference organizer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-26T00:30:05.870Z","global_importance":32,"audience_relevance":22,"importance_components":{"sampleSize":"n=10, preliminary","tickerTier":"small-cap HK-listed biotech","eventGravity":"positive early-stage clinical data at major congress","strategicSignificance":"first-in-class solid tumor CAR T moving into adjuvant setting"}},"durationMs":5524,"modelName":"glm-5.3-flashx"}}