[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635335":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Dual-target CD70\u002FCAIX CAR-NK cells after lymphodepletion","EXPERIMENTAL",null,[13,14],"Biological: EB-701\u002FCA9-NK","Drug: Fludarabine",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","EB-701\u002FCA9-NK","dual-target allogeneic CAR-NK cells (single infusion on Day 0; optional second infusion on Day 15 if safety criteria are met)",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Fludarabine","lymphodepletion",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":42,"coordinates":43},"Point",[44,45],114.0683,22.54554,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":11,"email":51},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100635335","phase-1-dual-target-cd70caix-car-nk-cells-for-advanced-clear-cell-renal-cell-carcinoma-100635335",false,"NCT07551349","Dual-target CD70\u002FCAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma","An Open-Label, Multicenter, Phase 1\u002F2 Study of Allogeneic Dual-target CD70\u002FCAIX (CA9) Chimeric Antigen Receptor Natural Killer Cells in Adults With Advanced or Metastatic Clear Cell Renal Cell Carcinoma","DUAL-NK RCC","Inclusion Criteria:\n\n* Written informed consent and willingness to comply with protocol procedures.\n* Age \\>= 18 years at the time of consent.\n* Histologically confirmed unresectable or metastatic clear cell RCC, or RCC with a clear-cell component, with radiographic progression after standard therapy.\n* Prior exposure to at least one PD-1 \u002F PD-L1-based regimen and at least one VEGF-pathway targeted regimen, or documented intolerance \u002F unsuitability for available standard systemic options.\n* At least one measurable lesion by RECIST 1.1.\n* Available archival tumor tissue or willingness to undergo fresh biopsy for central biomarker testing; protocoldefined tumor positivity for CD70 and\u002For CAIX is required. Dual-positive cases are preferred for the biomarkerexpansion portion.\n* ECOG performance status 0-1.\n* Adequate marrow, liver, cardiac, pulmonary, and renal function as defined by the protocol (for example, ANC, platelets, bilirubin, AST\u002FALT, creatinine clearance, oxygen saturation, and left ventricular function within protocoldefined limits).\n* Life expectancy of at least 12 weeks.\n* Negative pregnancy test for participants of childbearing potential and agreement to highly effective contraception during protocol-defined risk windows.\n* Previously treated brain metastases are allowed if clinically stable and off escalating corticosteroids for at least 14 days before lymphodepletion.\n\nExclusion Criteria:\n\n* Active, untreated, or symptomatic central nervous system metastases, leptomeningeal disease, or uncontrolled seizure disorder.\n* Prior gene-modified cellular therapy (including prior CAR-T, CAR-NK, CAR-NKT, or TCR-engineered therapy) within the protocol-defined washout window.\n* Prior allogeneic stem cell transplant or solid organ transplant with ongoing clinically significant immunosuppression.\n* Active autoimmune disease requiring systemic immunosuppressive treatment; physiologic replacement doses are permitted.\n* Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, tuberculosis, or sepsis.\n* Clinically significant hepatobiliary disease that could increase risk from CAIX-directed therapy, such as active cholangitis, primary sclerosing cholangitis, biliary obstruction, Child-Pugh B\u002FC cirrhosis, or prior hepatic venoocclusive disease.\n* Clinically significant cardiovascular disease (for example, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful heart failure).\n* Systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days before lymphodepletion, unless required as physiologic replacement.\n* Pregnancy or breastfeeding.\n* Another active invasive malignancy requiring systemic treatment, except for protocol-defined low-risk exceptions.\n* Known hypersensitivity to fludarabine, cyclophosphamide, or a critical study-product excipient.","ALL","18 Years",{"count":65,"type":66},36,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CD70\u002FCAIX CAR-NK cells after fludarabine\u002Fcyclophosphamide lymphodepletion in adults with advanced or metastatic clear cell RCC that has progressed after standard therapy. The study is designed to determine a recommended dose and schedule, characterize hepatobiliary safety, and explore whether CD70-high, CAIX-high, or dual-high tumors derive the greatest benefit. Biomarker-defined activity signals will be used to guide whether later development should prioritize CD70, CAIX\u002FCA9, or continued dual-targeting.",[73],"Advanced or Metastatic Clear Cell Renal Cell Carcinoma",[75,76,77],"RCC","kidney cancer","clear cell renal cell carcinoma","2026-04-18",{"date":80,"type":81},"2026-04-24","ACTUAL",{"date":83,"type":81},"2026-02-02",{"date":85,"type":66},"2028-04-17",{"name":5,"class":6},1]