[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642684":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":21,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":21,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EB-HC01 after lymphodepletion","EXPERIMENTAL","Participants with biomarker-confirmed HER2\u002FCEACAM5-positive advanced biliary tract cancer receive fludarabine plus cyclophosphamide on Days -5 to -3, followed by EB-HC01 intravenously on Days 0 and 7 of each 28-day cycle. Up to 2 cycles are permitted during doseescalation and up to 4 cycles are allowed in expansion in the absence of progression or prohibitive toxicity.",[13,14,15],"Biological: EB-HC01 dual-target CARNK cells","Drug: Fludarabine","Drug: Cyclophosphamide",[17,22,26],{"type":18,"name":19,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","EB-HC01 dual-target CARNK cells",[9],null,{"type":23,"name":24,"description":24,"armGroupLabels":25,"otherNames":21},"DRUG","Fludarabine",[9],{"type":23,"name":27,"description":27,"armGroupLabels":28,"otherNames":21},"Cyclophosphamide",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":21,"email":34},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":45,"coordinates":46},"Point",[47,48],114.0683,22.54554,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":21,"email":54},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":56,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684",false,"NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.","ALL","18 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[76,77,78,79,80],"Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma","Biliary Tract Cancer",[82,83,84,85,86,87,88,89,90,91,92],"CAR-NK","dual-target cell therapy","HER2","ERBB2","CEA","CEACAM5","cholangiocarcinoma","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","2026-06-06",{"date":95,"type":96},"2026-06-11","ACTUAL",{"date":98,"type":96},"2026-03-02",{"date":100,"type":69},"2028-10-17",{"name":5,"class":6},1]