{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":false},"commentary_summary":null,"drugs_tested":[["CLDN6 CAR-T","CLDN6 RNA-LPX"],["CLDN6 CAR-T"]],"indication":"CLDN6-positive relapsed or refractory advanced solid tumors","name":"BNT211-01","nct_id":"NCT04503278","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bnt211-01-nct04503278. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Dose escalation in lymphodepleted patients until the MTD and/or RP2D.","label":"Part 1 - CLDN6 CAR-T","type":"EXPERIMENTAL"},{"description":"Dose escalation until the MTD and/or RP2D.","label":"Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2041-08","type":"ESTIMATED"},"conditions":["Solid Tumor"],"enrollment":{"count":214,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"CLDN6 CAR-T","otherNames":[],"type":"BIOLOGICAL"},{"name":"CLDN6 uRNA-LPX/CLDN6 modRNA-LPX","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-06-18","lead_sponsor":"BioNTech Cell & Gene Therapies GmbH","official_title":"Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2028-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship","timeFrame":"up to 25 months"},{"measure":"Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs","timeFrame":"up to 25 months"},{"measure":"Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period","timeFrame":"Day 1 to day 28"}],"references":[{"citation":"Mackensen A, Haanen JBAG, Koenecke C, Alsdorf W, Wagner-Drouet E, Borchmann P, Heudobler D, Ferstl B, Klobuch S, Bokemeyer C, Desuki A, Luke F, Kutsch N, Muller F, Smit E, Hillemanns P, Karagiannis P, Wiegert E, He Y, Ho T, Kang-Fortner Q, Schlitter AM, Schulz-Eying C, Finlayson A, Flemmig C, Kuhlcke K, Preussner L, Rengstl B, Tureci O, Sahin U. CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial. Nat Med. 2023 Nov;29(11):2844-2853. doi: 10.1038/s41591-023-02612-0. Epub 2023 Oct 23.","pmid":"37872225","type":"DERIVED"},{"citation":"Simon AG, Lyu SI, Laible M, Woll S, Tureci O, Sahin U, Alakus H, Fahrig L, Zander T, Buettner R, Bruns CJ, Schroeder W, Gebauer F, Quaas A. The tight junction protein claudin 6 is a potential target for patient-individualized treatment in esophageal and gastric adenocarcinoma and is associated with poor prognosis. J Transl Med. 2023 Aug 17;21(1):552. doi: 10.1186/s12967-023-04433-8.","pmid":"37592303","type":"DERIVED"}],"start_date":{"date":"2020-09-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors","url":"https://clinicaltrials.gov/study/NCT04503278"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/bnt211-01-nct04503278"}