[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639843":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":37,"interventions":45,"overallOfficials":11,"centralContacts":11,"locations":55,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},{"fullName":5,"class":6},"Genovn Therapeutics PTE. LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Dose-Limiting Toxicity (DLT)",null,"Within 28 days after first infusion",[14,17,20,23],{"measure":15,"description":11,"timeFrame":16},"Objective Response Rate (ORR)","Every 4 weeks for the first 6 months, then every 12 weeks through 24 months",{"measure":18,"description":11,"timeFrame":19},"Duration of Response (DOR)","From date of first documented response until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months",{"measure":21,"description":11,"timeFrame":22},"Progression-Free Survival (PFS)","From date of enrollment until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months",{"measure":24,"description":11,"timeFrame":25},"Overall Survival (OS)","From date of enrollment until date of death from any cause, assessed up to 24 months",[27],{"measure":28,"description":11,"timeFrame":29},"Expansion and persistence of IL-15 enhanced engineered NK cells and cytokine levels","Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, Day 28, then every 4 weeks through 6 months, then every 12 weeks through 12 months",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"NA","SINGLE_GROUP","IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"IL-15 Enhanced Engineered NK Cells","EXPERIMENTAL","Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy.",[43,44],"Drug: IL-15 enhanced engineered NK cells","Biological: IL-15 Enhanced Engineered NK Cells",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"DRUG","IL-15 enhanced engineered NK cells","Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.",[39],{"type":52,"name":39,"description":53,"armGroupLabels":54,"otherNames":11},"BIOLOGICAL","Genetically engineered NK cells expressing IL-15",[39],[56],{"facility":57,"status":58,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Xinqiao Hospital","RECRUITING","Chongqing","China","CN",{"type":63,"coordinates":64},"Point",[65,66],106.55771,29.56026,{"lat":66,"lon":65},[69],{"name":57,"role":70,"phone":71,"phoneExt":11,"email":72},"CONTACT","+86-23-68763468","jiaqingzhu0801@outlook.com",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639843","early-phase-1-il-15-enhanced-nk-cell-therapy-for-solid-tumors-100639843",false,"NCT07621471","IL-15 Enhanced NK Cell Therapy for Solid Tumors","A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age 18-70 years;\n2. ECOG 0-1;\n3. histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);\n4. failed prior standard therapy;\n5. \\>=1 measurable lesion per RECIST 1.1;\n6. adequate bone marrow, liver, kidney, and coagulation function;\n7. recovered from prior treatment toxicities;\n8. signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy\u002Flactation;\n2. other malignancy within 5 years (except cured localized tumors);\n3. active autoimmune disease or immunodeficiency;\n4. uncontrolled cardiovascular disease or infection;\n5. active TB;\n6. positive HBsAg\u002FHBcAb or HCV antibody (unless viral load undetectable);\n7. positive syphilis antibody;\n8. major surgery or vaccination within 28 days;\n9. prior cell therapy;\n10. severe allergy to study drugs;\n11. investigator judged unsuitable.","ALL","18 Years","70 Years",{"count":86,"type":87},12,"ESTIMATED","INTERVENTIONAL",[90],"EARLY_PHASE1","A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.",[93,94],"Solid Tumors","Metastatic Cancer","2026-09-27",{"date":97,"type":98},"2026-09-30","ACTUAL",{"date":100,"type":87},"2026-10-08",{"date":102,"type":87},"2028-12-31",{"name":104,"class":6},"Genovn Therapeutics (Suzhou) Co., Ltd.",1]