[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-clear-cell-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-clear-cell-renal-cell-carcinoma":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"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":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Advanced or Metastatic Clear Cell Renal Cell Carcinoma",[29,30,31],"RCC","kidney cancer","clear cell renal cell carcinoma","RECRUITING","2026-04-18",{"date":35,"type":36},"2026-04-24","ACTUAL",{"date":38,"type":36},"2026-02-02",{"date":40,"type":20},"2028-04-17",{"name":42,"class":43},"Beijing Biotech","INDUSTRY",""]