[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638606":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":36,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":36,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EBNK-1822H2 after lymphodepletion","EXPERIMENTAL","Participants receive fludarabine and cyclophosphamide lymphodepletion followed by intravenous infusion of allogeneic dual-target CLDN18.2\u002FHER2 CAR-NK cells on Day 0. A protocol-defined repeat infusion on Day 21 may be permitted in dose expansion if safety criteria are met.",[13,14,15],"Biological: EBNK-1822H2 dual-target CLDN18.2\u002FHER2 CAR-NK cells","Drug: Fludarabine","Drug: Cyclophosphamide",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","EBNK-1822H2 dual-target CLDN18.2\u002FHER2 CAR-NK cells","Illustrative allogeneic cord blood-derived NK-cell product engineered to recognize CLDN18.2 and HER2.",[9],[23],"Dual-target CAR-NK; EBNK-1822H2",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Fludarabine","Lymphodepletion backbone",[9],[30],"Fludara",{"type":25,"name":32,"description":27,"armGroupLabels":33,"otherNames":34},"Cyclophosphamide",[9],[35],"Cytoxan",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":53,"coordinates":54},"Point",[55,56],114.0683,22.54554,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":36,"email":62},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":64,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100638606","phase-1-dual-target-cldn182her2-car-nk-cells-for-advanced-esophageal-adenocarcinoma-100638606",false,"NCT07622940","Dual-Target CLDN18.2\u002FHER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target CLDN18.2\u002FHER2 Chimeric Antigen Receptor Natural Killer Cells (EBNK-1822H2) in Adults With Relapsed, Refractory, or Metastatic Esophageal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed esophageal adenocarcinoma or Siewert I\u002FII gastroesophageal junction adenocarcinoma judged biologically consistent with esophageal adenocarcinoma, unresectable\u002Frecurrent\u002Fmetastatic, and not amenable to curative therapy.\n* Disease progressed after at least 1 prior systemic regimen for advanced disease, or the participant is intolerant of \u002F ineligible for standard therapy. Biomarker-directed therapy must have been received or deemed inappropriate\u002Funavailable where standard in the local setting.\n* At least 1 measurable lesion by RECIST v1.1.\n* Evidence of at least one selected target: CLDN18.2-positive by validated IHC (example threshold: membranous staining in\n\n  ≥75% of tumor cells with moderate\u002Fstrong intensity or protocol-specified central threshold), and\u002For HER2-positive by IHC 3+ or IHC 2+\u002FISH-amplified disease.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, pulmonary, and cardiac function per protocol laboratory thresholds.\n* Life expectancy ≥12 weeks.\n* Resolution of clinically significant prior-therapy toxicities to grade ≤1 (except alopecia or stable endocrinopathies).\n* Willingness to provide archival tumor tissue and to undergo fresh biopsy when safely feasible.\n* Negative pregnancy test for participants of childbearing potential and agreement to protocol-defined contraception.\n\nExclusion Criteria:\n\n* Esophageal squamous cell carcinoma or non-adenocarcinoma histology.\n* Known active CNS metastases or leptomeningeal disease; previously treated stable CNS disease may be allowed only if asymptomatic and off escalating steroids per protocol.\n* Prior gene-modified cellular therapy within 12 weeks, or another investigational therapy likely to confound interpretation of safety or efficacy.\n* Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV viremia, sepsis, or clinically significant opportunistic infection.\n* Ongoing systemic immunosuppressive therapy above physiologic steroid replacement.\n* Active autoimmune disease requiring systemic treatment within 2 years.\n* Clinically significant interstitial lung disease\u002Fpneumonitis, uncontrolled cardiovascular disease, or left ventricular ejection fraction \\\u003C50%.\n* Active gastrointestinal perforation, uncontrolled bleeding, or clinically significant mucosal ulceration that would increase study-treatment risk.\n* Prior solid organ transplant or active graft-versus-host disease.\n* Pregnant or breastfeeding.\n* Another active malignancy requiring systemic therapy, except protocol-permitted low-risk cancers.","ALL","18 Years","75 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This example study evaluates the safety, feasibility, cellular kinetics, and preliminary anti-tumor activity of EBNK-1822H2, an illustrative allogeneic cord blood-derived dual-target CAR-NK cell product directed against CLDN18.2 and HER2, in adults with relapsed\u002Frefractory or metastatic esophageal adenocarcinoma after standard therapy. The study uses dose escalation followed by biomarker-defined expansion and prospectively records EGFR expression as an exploratory biomarker of antigen escape.",[84,85],"Recurrent or Metastatic Esophageal Adenocarcinoma","Biomarker-selected CLDN18.2-positive and\u002For HER2-positive Disease",[87,88,89,90,91,92,93,94,95,96],"CAR-NK","Allogeneic NK cells","Cellular immunotherapy","CLDN18.2","HER2 (ERBB2)","EGFR (exploratory biomarker)","Esophageal adenocarcinoma","Gastroesophageal junction adenocarcinoma","Dose escalation","Dose expansion","2026-05-31",{"date":99,"type":100},"2026-06-03","ACTUAL",{"date":102,"type":100},"2026-03-02",{"date":104,"type":77},"2028-03-17",{"name":5,"class":6},1]