{"entity":{"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","aka":[],"tldr":"The first randomised trial of CAR-T cells in a solid tumour: in heavily pretreated Claudin 18.2-positive stomach cancer, satri-cel held the disease for a median of 3.25 months against 1.77 months on the doctor's choice of drug, with almost universal cytokine release syndrome.","summary":"Open-label, multicentre, randomised controlled phase 2 trial in China in patients with CLDN18.2-positive (immunohistochemistry intensity at least 2+ and at least 40 percent positive tumour cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two previous lines. Patients were randomly allocated 2:1 to satri-cel (up to three infusions of 250 million cells) or treatment of physician's choice (nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib), with crossover to satri-cel allowed after progression or intolerance. The primary endpoint was progression-free survival by independent review committee in the intention-to-treat population.\n\nBetween March 2022 and July 2024, 266 patients were screened and 156 randomised (104 satri-cel, 52 physician's choice); 88 (85 percent) and 48 (92 percent) received study drug. Median progression-free survival was 3.25 months (95% CI 2.86 to 4.53) with satri-cel and 1.77 months (95% CI 1.61 to 2.04) with physician's choice (hazard ratio 0.37, 95% CI 0.24 to 0.56; one-sided log-rank p<0.0001). Grade 3 or higher treatment-emergent adverse events occurred in 87 of 88 (99 percent) treated satri-cel patients and 30 of 48 (63 percent) on physician's choice; cytokine release syndrome occurred in 84 of 88 (95 percent). Funded by CARsgen Therapeutics.","asOf":"2026-09-24","links":[{"label":"The Lancet 2025","url":"https://doi.org/10.1016/S0140-6736(25)00860-8"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40460847/"},{"label":"ClinicalTrials.gov NCT04581473","url":"https://clinicaltrials.gov/study/NCT04581473"}],"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":["nct04581473"],"people":["qi-changsong","shen-lin"],"bottlenecks":[],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2025,"doi":"10.1016/S0140-6736(25)00860-8","pmid":"40460847","authors":"Qi C, Liu C, Peng Z, et al.","paperType":"rct","findings":["Median progression-free survival 3.25 vs 1.77 months; hazard ratio 0.37 (95% CI 0.24 to 0.56), one-sided log-rank p<0.0001.","156 randomised of 266 screened; 85% of the satri-cel arm and 92% of the physician's choice arm received study drug.","Grade 3 or higher treatment-emergent adverse events in 99% vs 63% of treated patients; cytokine release syndrome in 95% of treated satri-cel patients."],"whatItMeans":"This is the trial behind the first approval of a CAR-T therapy for a solid tumour, in China. The gain in progression-free survival is real but measured in weeks, 15 percent of patients randomised to satri-cel never received it, and nearly every treated patient had cytokine release syndrome, so the trade-off is very different from CAR-T in blood cancers. Overall survival is not reported in the abstract.","caveats":["Open-label, 2:1 randomisation, and crossover from physician's choice to satri-cel was allowed, which complicates any later survival comparison.","The abstract reports no overall survival figures.","Requires Claudin 18.2 testing by immunohistochemistry and manufacturing time; 16 of 104 randomised patients did not receive satri-cel."],"changedPractice":true,"participants":156},"route":"/key-papers/paper-ct041-st-01-lancet-2025/","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/"}],"trial":[{"id":"nct04581473","kind":"trial","name":"CT041-ST-01","route":"/trials/nct04581473/"}],"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/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}]}}