{"entity":{"id":"nct04581473","kind":"trial","name":"CT041-ST-01","aka":["CT041 ST-01","satri-cel CT041-ST-01","Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection"],"tldr":"The Chinese randomised trial in which Claudin 18.2 CAR-T cells delayed progression compared with the doctor's choice of later-line drugs in stomach cancer, the first randomised trial of CAR-T cells in a solid tumour.","summary":"CT041-ST-01 is an open-label, multicentre phase Ib/II programme of satricabtagene autoleucel (satri-cel, CT041), an autologous Claudin 18.2 CAR-T, sponsored by CARsgen. The pivotal phase 2 portion randomised patients in China with Claudin 18.2-positive (immunohistochemistry intensity at least 2+ in at least 40 percent of tumour cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two previous lines, 2 to 1, to satri-cel or treatment of physician's choice (nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib). Satri-cel was infused up to three times at 250 million cells. Patients on physician's choice could receive satri-cel after progression or intolerance. The primary endpoint was progression-free survival by independent review in the intention-to-treat population.\n\nBetween March 2022 and July 2024, 266 patients were screened and 156 randomised (104 to satri-cel and 52 to physician's choice); 88 and 48 received study treatment. Median progression-free survival was 3.25 months with satri-cel versus 1.77 months with physician's choice (hazard ratio 0.37, 95% CI 0.24 to 0.56, one-sided log-rank p less than 0.0001). The authors describe it as the first randomised controlled trial of CAR T-cell therapy in solid tumours and conclude that it supports satri-cel as a third-line option (The Lancet 2025). The abstract does not report overall survival.\n\nSatri-cel is approved in China for Claudin 18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after earlier lines on this trial (see the drug record). The registry lists the broader phase Ib/II shell as active and no longer recruiting, with an estimated 192 participants including pancreatic cohorts that are outside this phase 2 report.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04581473","url":"https://clinicaltrials.gov/study/NCT04581473"},{"label":"The Lancet 2025","url":"https://doi.org/10.1016/S0140-6736(25)00860-8"}],"tags":["china"],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":["car-t"],"targets":["cldn18-2"],"drugs":["satricabtagene-autoleucel"],"companies":["carsgen"],"institutions":["pku-cancer-hospital"],"pathways":[],"terms":[],"trials":[],"people":["qi-changsong","shen-lin"],"bottlenecks":[],"keyPapers":["paper-ct041-st-01-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04581473","phase":"1/2","setting":"CLDN18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines, China: satricabtagene autoleucel versus treatment of physician's choice","sponsor":"CARsgen Therapeutics Co., Ltd.","result":"Median progression-free survival 3.25 vs 1.77 months (hazard ratio 0.37) in 156 randomised patients.","started":"2020-10-23","startedType":"actual","yearReported":2025,"enrolled":156,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov estimates 192 for the whole phase Ib/II registration (gastric and pancreatic cohorts); 156 were randomised in the phase 2 gastric or gastro-oesophageal junction cohort reported in The Lancet.","outcomes":[{"endpoint":"Progression-free survival (independent review, intention-to-treat)","primary":true,"unit":"months","arms":[{"name":"Satricabtagene autoleucel","n":104,"value":3.25,"note":"95% CI 2.86 to 4.53"},{"name":"Treatment of physician's choice","n":52,"value":1.77,"note":"95% CI 1.61 to 2.04"}],"hr":0.37,"ci":[0.24,0.56],"p":"<0.0001 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(25)00860-8"}]},"route":"/trials/nct04581473/","neighbours":{"cancer":[{"id":"gastric-cldn18-2-positive","kind":"cancer","name":"Claudin 18.2-positive gastric cancer","route":"/cancers/gastric-cldn18-2-positive/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cldn18-2","kind":"target","name":"Claudin 18.2","route":"/targets/cldn18-2/"}],"drug":[{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","route":"/drugs/satricabtagene-autoleucel/"}],"company":[{"id":"carsgen","kind":"company","name":"CARsgen Therapeutics","route":"/companies/carsgen/"}],"institution":[{"id":"pku-cancer-hospital","kind":"institution","name":"Peking University Cancer Hospital","route":"/institutions/pku-cancer-hospital/"}],"person":[{"id":"qi-changsong","kind":"person","name":"Changsong Qi","route":"/people/qi-changsong/"},{"id":"shen-lin","kind":"person","name":"Lin Shen","route":"/people/shen-lin/"}],"paper":[{"id":"paper-ct041-st-01-lancet-2025","kind":"paper","name":"Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial","route":"/key-papers/paper-ct041-st-01-lancet-2025/"}]}}