{"entity":{"id":"satricabtagene-autoleucel","kind":"drug","name":"Satricabtagene autoleucel","aka":[],"tldr":"Satricabtagene autoleucel (satri-cel) is the first CAR-T therapy approved for a solid tumour (gastric cancer), in China.","summary":"Satricabtagene autoleucel (satri-cel) is an autologous CAR-T built from a humanised scFv against Claudin 18.2, a tight-junction protein normally confined to gastric mucosa and exposed on a large share of gastric and pancreatic adenocarcinomas; lymphodepletion uses a nab-paclitaxel-containing regimen. CARsgen developed it. In the randomised phase 2 CT041-ST-01 trial in China (Lancet 2025), satri-cel improved progression-free survival versus physician's choice in pretreated CLDN18.2-positive gastric or gastro-oesophageal junction cancer (median 3.25 versus 1.77 months; the abstract reports no overall survival figures), and NMPA approval followed in 2025-26 per company reports; the phase 2 dose was 2.5 x 10^8 CAR-positive T cells. Cytokine release syndrome and cytopenias occur, and gastric mucosal injury is an expected on-target effect. US trials are ongoing, and durability and use in pancreatic cancer remain open. For a newcomer: the first CAR-T approved anywhere for a solid tumour.","status":"approved","asOf":"2026-09-24","links":[{"label":"CT041-ST-01 (Lancet 2025)","url":"https://doi.org/10.1016/S0140-6736(25)00860-8"}],"tags":[],"related":[],"cancers":["gastric","pancreatic"],"sections":[],"technologies":["car-t"],"targets":["cldn18-2"],"drugs":[],"companies":["carsgen"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04581473"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"satri-cel, CT041","modality":"CAR-T (Claudin 18.2)","mechanism":"Humanised CLDN18.2 scFv CAR-T; lymphodepletion with nab-paclitaxel-containing regimen.","approvals":[{"region":"China","year":2025,"indication":"CLDN18.2+ advanced gastric/GEJ adenocarcinoma, previously treated"}],"mechanismSteps":["Patient's T cells are collected by leukapheresis","Cells are engineered to express a CAR against Claudin 18.2 and expanded","Patient receives lymphodepleting chemotherapy","CAR-T cells are infused, home to tumour, and expand","CAR binds Claudin 18.2; T cell kills the tumour cell and proliferates","Memory CAR-T cells persist and patrol"],"dosing":{"route":"Single IV infusion after lymphodepletion","schedule":"2.5 × 10⁸ CAR+ T cells (phase 2 dose); lymphodepletion includes nab-paclitaxel, fludarabine, cyclophosphamide","monitoring":"CRS, gastric mucosal injury (on-target), cytopenias","source":"https://www.carsgen.com"},"toxicity":[{"event":"Cytokine release syndrome"},{"event":"Gastric mucosal injury / nausea"},{"event":"Cytopenias"},{"event":"Infections"}],"access":[{"country":"CN","reimbursement":"NMPA approved 2025-26; self-pay","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2022-01","type":"designation","region":"US","note":"RMAT designation, CLDN18.2+ gastric cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-09","type":"approval","region":"China","note":"First CAR-T approved for a solid tumour (CLDN18.2+ gastric/GEJ adenocarcinoma)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/satricabtagene-autoleucel/","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/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"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/"}],"company":[{"id":"carsgen","kind":"company","name":"CARsgen Therapeutics","route":"/companies/carsgen/"}],"trial":[{"id":"nct04581473","kind":"trial","name":"CT041-ST-01","route":"/trials/nct04581473/"}],"pairing":[{"id":"cldn18-antibody-then-adc","kind":"pairing","name":"CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression","route":"/pairings/cldn18-antibody-then-adc/"}],"idea":[{"id":"idea-in-vivo-car-solid","kind":"idea","name":"In vivo CAR-T against solid-tumour antigens","route":"/ideas/idea-in-vivo-car-solid/"},{"id":"idea-peritoneal-directed-gastric","kind":"idea","name":"Peritoneal-directed therapy for gastric cancer","route":"/ideas/idea-peritoneal-directed-gastric/"}],"roadmap":[{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"}],"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/"},{"id":"li-zonghai","kind":"person","name":"Zonghai Li","route":"/people/li-zonghai/"}],"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/"}],"institution":[{"id":"pku-cancer-hospital","kind":"institution","name":"Peking University Cancer Hospital","route":"/institutions/pku-cancer-hospital/"},{"id":"renji-hospital","kind":"institution","name":"Renji Hospital, Shanghai Jiao Tong University","route":"/institutions/renji-hospital/"}]}}