{"preliminary_commentary":{"by_channel":{"x_thread":14,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04581473\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"CT041-ST-01","nct_id":"NCT04581473","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ct041-st-01-nct04581473. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety","label":"CT041 autologous CAR T-cell injection","type":"EXPERIMENTAL"},{"description":"Participants will receive physician's choice of treatment in Phase II","label":"Physician's Choice","type":"ACTIVE_COMPARATOR"}],"collaborators":["Peking University Cancer Hospital & Institute","Fudan University"],"completion_date":{"date":"2038-06-30","type":"ESTIMATED"},"conditions":["Gastric Adenocarcinoma","Pancreatic Cancer","Gastroesophageal Junction Adenocarcinoma"],"enrollment":{"count":192,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"CT041 autologous CAR T-cell injection","otherNames":["CAR T-cell injection"],"type":"DRUG"},{"name":"Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）","otherNames":["Best support care(BSC)"],"type":"DRUG"}],"last_update":"2025-06-05","lead_sponsor":"CARsgen Therapeutics Co., Ltd.","official_title":"An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-10-18","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase Ib: Incidence of Treatment Related adverse events (AEs)","timeFrame":"Up to 18 months"},{"measure":"Phase Ib: Identification of Maximum Tolerated Dose (MTD)","timeFrame":"day1-day28"},{"measure":"Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice","timeFrame":"Up to 24 months"}],"references":[{"citation":"Qi C, Liu C, Peng Z, Zhang Y, Wei J, Qiu W, Zhang X, Pan H, Niu Z, Qiu M, Qin Y, Fang W, Ye F, Li N, Liu T, Liu A, Zhang X, Hu C, Zhang J, Cui J, Lin X, Wang S, Zhang J, Lin T, Qu X, Yuan X, Gong J, Li J, Gao W, Gai L, Wang Y, Yuan D, Li Z, Shen L. 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. Lancet. 2025 Jun 7;405(10494):2049-2060. doi: 10.1016/S0140-6736(25)00860-8. Epub 2025 May 31.","pmid":"40460847","type":"DERIVED"},{"citation":"Qi C, Zhang P, Liu C, Zhang J, Zhou J, Yuan J, Liu D, Zhang M, Gong J, Wang X, Li J, Zhang X, Li N, Peng X, Liu Z, Yuan D, Baffa R, Wang Y, Shen L. Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. J Clin Oncol. 2024 Jul 20;42(21):2565-2577. doi: 10.1200/JCO.23.02314. Epub 2024 May 24.","pmid":"38788174","type":"DERIVED"},{"citation":"Qi C, Xie T, Zhou J, Wang X, Gong J, Zhang X, Li J, Yuan J, Liu C, Shen L. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol. 2023 Sep 9;16(1):102. doi: 10.1186/s13045-023-01491-9.","pmid":"37689733","type":"DERIVED"}],"start_date":{"date":"2020-10-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection","url":"https://clinicaltrials.gov/study/NCT04581473"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ct041-st-01-nct04581473"}