[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630819":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":38,"locations":44,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Participants receive lymphodepletion with cyclophosphamide and fludarabine followed by EB-DT-NK-UC101 IV infusions on Day 1 and Day 8 of a 21-day cycle. Planned dose levels: 1 × 10\\^7, 3 × 10\\^7, and 1 × 10\\^8 CAR-NK cells\u002Fkg",[13,14,15],"Biological: EB-DT-NK-UC101","Drug: Cyclophosphamide","Drug: Fludarabine",{"label":17,"type":10,"description":18,"interventionNames":19},"Dose Expansion","Participants receive the RP2D identified in Arm A using the same lymphodepletion backbone and infusion schedule. Expansion enriches for Nectin-4-positive disease and captures HER2 co-expression prospectively.",[13,14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","EB-DT-NK-UC101","Allogeneic cord-blood-derived dual-target Nectin-4\u002FHER2 CAR-NK cells with inducible caspase-9 safety switch.",[9,17],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Cyclophosphamide","Lymphodepleting chemotherapy given before the first CAR-NK infusion.",[9,17],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Fludarabine","Lymphodepleting chemotherapy given before the first CAR-NK infusion",[9,17],[37],"lymphodepletion",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":54,"coordinates":55},"Point",[56,57],114.0683,22.54554,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":26,"email":63},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100630819","phase-1-dual-target-nectin-4her2-car-nk-cells-in-advanced-urothelial-carcinoma-100630819",false,"NCT07492628","Dual-Target Nectin-4\u002FHER2 CAR-NK Cells in Advanced Urothelial Carcinoma","A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target Nectin-4\u002FHER2 CAR-NK Cells Following Fludarabine\u002FCyclophosphamide Lymphodepletion in Adults With Relapsed\u002FRefractory, Locally Advanced or Metastatic Urothelial Carcinoma","DUET-UC-NK","Inclusion Criteria:\n\n* Age 18-75 years at consent.\n* Histologically confirmed urothelial carcinoma of the bladder, ureter, renal pelvis, or urethra that is unresectable locally advanced or metastatic.\n* Disease progression after, intolerance to, or ineligibility for standard therapy, including platinum-based chemotherapy and PD-1\u002FPD-L1 blockade when appropriate for the patient and region. Prior enfortumab vedotin and prior HER2-directed therapy are allowed, but a fresh biopsy is strongly preferred after the latest systemic regimen.\n* At least one measurable lesion per RECIST v1.1.\n* Tumor tissue available for central review demonstrating Nectin-4 positivity (for example, IHC ≥1+ in ≥10% tumor cells) and HER2 status assessed by IHC\u002FISH. At least one of the selected therapeutic targets must be present; dose expansion preferentially enrolls Nectin-4-positive disease.\n* ECOG performance status 0-1.\n* Adequate bone marrow, hepatic, renal, and coagulation function.\n* Life expectancy of at least 12 weeks.\n* Negative pregnancy test for women of childbearing potential and agreement to use highly effective contraception during study treatment and follow-up as defined in the protocol.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Active or untreated central nervous system metastases or leptomeningeal disease. Previously treated CNS disease is allowed if clinically stable and off escalating corticosteroids.\n* Prior allogeneic hematopoietic stem cell transplant, prior solid-organ transplant, or active graft-versus-host disease.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the defined washout window.\n* Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, sepsis, or active tuberculosis.\n* Clinically significant cardiac disease, active myocarditis, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful decline in left ventricular ejection fraction that would increase risk from HER2-directed cell therapy.\n* Clinically significant pulmonary disease (for example, uncontrolled interstitial lung disease or oxygen-dependent respiratory compromise).\n* Use of systemic corticosteroids or other immunosuppressive medications above protocol-allowed limits within the washout window.\n* History of severe hypersensitivity to fludarabine, cyclophosphamide, or cell-product excipients.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy or likely to interfere with protocol assessments, except for protocol-allowed low-risk cancers.","ALL","18 Years","75 Years",{"count":78,"type":79},42,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4\u002FHER2 CAR-NK cell product in adults with relapsed\u002Frefractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical validation; HER2\u002FERBB2 was chosen as the secondary co-target to broaden tumor coverage and reduce antigen-escape risk. EpCAM is not selected as a therapeutic co-target in this example because of broader normal epithelial expression and weaker tumor specificity in urothelial carcinoma.",[85,86,87,88,89],"Bladder Cancer","Urothelial Carcinoma","Metastatic Urothelial Carcinoma","Locally Advanced Urothelial Carcinoma","Upper Tract Urothelial Carcinoma",[91,92,93,94,95,96,97,98,37,99,100,101],"CAR-NK","allogeneic NK cells","Nectin-4","HER2","ERBB2","urothelial carcinoma","bladder cancer","dual-target","solid tumor immunotherapy","EpCAM","RP2D","2026-03-20",{"date":104,"type":105},"2026-03-25","ACTUAL",{"date":107,"type":105},"2026-03-02",{"date":109,"type":79},"2028-05-17",{"name":5,"class":6},1]