[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-or-metastatic-esophageal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-or-metastatic-esophageal-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29],"Recurrent or Metastatic Esophageal Adenocarcinoma","Biomarker-selected CLDN18.2-positive and\u002For HER2-positive Disease",[31,32,33,34,35,36,37,38,39,40],"CAR-NK","Allogeneic NK cells","Cellular immunotherapy","CLDN18.2","HER2 (ERBB2)","EGFR (exploratory biomarker)","Esophageal adenocarcinoma","Gastroesophageal junction adenocarcinoma","Dose escalation","Dose expansion","RECRUITING","2026-05-31",{"date":44,"type":45},"2026-06-03","ACTUAL",{"date":47,"type":45},"2026-03-02",{"date":49,"type":21},"2028-03-17",{"name":51,"class":52},"Beijing Biotech","INDUSTRY"]