[{"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":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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Advanced or Metastatic Clear Cell Renal Cell Carcinoma",[30,31,32],"RCC","kidney cancer","clear cell renal cell carcinoma","RECRUITING","2026-04-18",{"date":36,"type":37},"2026-04-24","ACTUAL",{"date":39,"type":37},"2026-02-02",{"date":41,"type":21},"2028-04-17",{"name":43,"class":44},"Beijing Biotech","INDUSTRY"]