[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631403":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":34,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":34,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EB-G3B7-NK dual-target CAR-NK cells","EXPERIMENTAL","Adults with biomarker-confirmed advanced HCC receive fludarabine\u002Fcyclophosphamide lymphodepletion followed by allogeneic dual-target GPC3\u002FB7-H3 CAR-NK cells at an assigned dose level in Phase 1 or at the RP2D in Phase 2.",[13,14,15],"Biological: EB-G3B7-NK dual-target CAR-NK cells","Drug: Fludarabine","Drug: Cyclophosphamide",[17,23,30],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Allogeneic donor-derived NK cells genetically modified to express a dual-target CAR recognizing GPC3 and B7-H3\u002FCD276. Administered intravenously after lymphodepletion.",[9],[22],"Dual-target GPC3\u002FB7-H3 CAR-NK; G3B7-NK; EB-G3B7-NK",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Fludarabine","Lymphodepleting chemotherapy given before CAR-NK infusion.",[9],[29],"FC lymphodepletion",{"type":24,"name":31,"description":26,"armGroupLabels":32,"otherNames":33},"Cyclophosphamide",[9],[29],null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.0683,22.54554,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":34,"email":60},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":62,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100631403","phase-1-dual-target-gpc3b7-h3-car-nk-cells-for-advanced-hcc-100631403",false,"NCT07500220","Dual-Target GPC3\u002FB7-H3 CAR-NK Cells for Advanced HCC","A Phase 1\u002F2, Open-Label, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target GPC3\u002FB7-H3 (CD276) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Relapsed\u002FRefractory, or Metastatic Hepatocellular Carcinoma","DUET-HCC","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Histologically or cytologically confirmed HCC, or radiologically diagnosed HCC with mandatory tissue confirmation of target expression before enrollment.\n* Unresectable, locally advanced, or metastatic HCC not amenable to curative surgery, transplant, or further locoregional therapy; BCLC stage C, or stage B that is not suitable for or has progressed after locoregional therapy.\n* Disease progression on, intolerance to, or ineligibility for at least 1 prior standard systemic regimen.\n* Central pathology showing GPC3 positivity in \\>=25% of viable tumor cells by IHC and B7-H3 positivity in \\>=10% of tumor cells and\u002For tumor-associated stromal\u002Fvascular cells by IHC.\n* At least 1 measurable lesion by RECIST 1.1; intrahepatic lesions must be assessable by contrast-enhanced triphasic CT or MRI.\n* ECOG performance status 0 to 1.\n* Child-Pugh class A or stable Child-Pugh B7 without uncontrolled ascites or recent encephalopathy.\n* Estimated life expectancy \\>=12 weeks.\n* Adequate organ function: WBC \\>=2.5 x 10\\^9\u002FL; platelets \\>=60 x 10\\^9\u002FL; hemoglobin \\>=9 g\u002FdL; serum albumin \\>=30 g\u002FL; creatinine clearance \\>=40 mL\u002Fmin; AST\u002FALT \\\u003C=5 x ULN; total bilirubin \\\u003C=2.5 x ULN; INR\u002Fprothrombin time within protocol-defined range.\n* If HBsAg positive or anti-HBc positive, HBV DNA must be \\\u003C200 IU\u002FmL and the participant must be on appropriate antiviral therapy before lymphodepletion. Controlled HCV is allowed if per protocol.\n* Negative serum pregnancy test for participants of childbearing potential and agreement to effective contraception.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Prior gene-modified cellular therapy (for example prior CAR-T, CAR-NK, or TCR-engineered therapy) within the protocol-defined washout period or with unresolved clinically significant toxicity.\n* Active, uncontrolled infection, including uncontrolled bacterial, viral, or fungal infection; uncontrolled HIV; active HBV or HCV with uncontrolled viral load; or active tuberculosis.\n* Known active CNS metastases or leptomeningeal disease requiring escalating steroids or urgent local intervention.\n* Liver transplant or other solid-organ transplant history, or current requirement for chronic immunosuppression.\n* Clinically significant ascites requiring frequent drainage, grade \\>=2 hepatic encephalopathy within 4 weeks, or recent clinically significant variceal\u002FGI bleeding.\n* Extensive liver replacement by tumor (for example \\>=70%) or complete major portal vein\u002Fhepatic venous obstruction judged to create excessive treatment risk.\n* Major surgery, locoregional therapy, radiotherapy, or systemic anticancer therapy too close to lymphodepletion per protocol-defined washout period.\n* Active autoimmune disease requiring systemic immunosuppressive therapy, or chronic systemic corticosteroids above protocol threshold.\n* Clinically significant cardiovascular disease (recent myocardial infarction, unstable arrhythmia, uncontrolled heart failure), uncontrolled pulmonary disease, or other serious comorbidity that materially increases study risk.\n* Pregnant or breastfeeding.\n* Any other active malignancy that is progressing or requires current systemic treatment.\n* Any medical or psychiatric condition that, in the investigator's judgment, would compromise safety, protocol compliance, or interpretation of results.","ALL","18 Years","75 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","open-label trial of an allogeneic dual-target CAR-NK product directed against GPC3 and B7-H3 for adults with advanced hepatocellular carcinoma. The design intentionally uses GPC3 as the primary target anchor because GPC3 is the dominant HCC cell-therapy antigen in current clinical development, while adding B7-H3 to reduce antigen escape and to broaden coverage across tumor and tumor-microenvironment compartments. The study first evaluates safety and dose-limiting toxicities, then expands at the recommended phase 2 dose.",[83,84],"Advanced Hepatocellular Carcinoma (HCC)","Metastatic Liver Cancer",[86,87,88,89,90,91,92,93,94,95,96,97,98,99],"HCC","liver cancer","epatocellular carcinoma","GPC3","glypican-3","B7-H3","CD276","CAR-NK","dual-target","NK cell therapy","adoptive cell therapy","cell therapy","immunotherapy","allogeneic","2026-03-24",{"date":102,"type":103},"2026-03-30","ACTUAL",{"date":105,"type":103},"2026-03-02",{"date":107,"type":76},"2028-03-17",{"name":5,"class":6},1]