[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641091":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":30,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Dose-escalation safety lead-in","EXPERIMENTAL","Target-positive adults with unresectable\u002Fmetastatic cutaneous melanoma or metastatic uveal melanoma receive lymphodepletion followed by EB-DTKN-401 at one of three planned dose levels; up to three infusions over 15 days.",[13,14,15],"Biological: EB-DTKN-401 allogeneic dual-target CSPG4\u002FGD2 CAR-NK cells","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B: Cutaneous expansion","Participants with target-positive unresectable\u002Fmetastatic cutaneous melanoma receive the RP2D after the same lymphodepleting regimen.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Arm C:Uveal expansion","Participants with target-positive metastatic uveal melanoma receive the RP2D after the same lymphodepleting regimen.",[13,14,15],[25,31,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","EB-DTKN-401 allogeneic dual-target CSPG4\u002FGD2 CAR-NK cells","Genetically engineered natural killer (NK) cells expressing dual chimeric antigen receptors targeting CSPG4 and GD2 are expanded ex vivo and infused (IV) into patients. These cells recognize tumor antigens and induce targeted cytotoxicity, aiming to improve tumor killing and reduce antigen escape in CSPG4\u002FGD2-positive cancers.",[9,17,21],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Fludarabine","Fludara",[9,17,21],[34],{"type":32,"name":38,"description":38,"armGroupLabels":39,"otherNames":30},"Cyclophosphamide",[9,17,21],[41],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":56,"coordinates":57},"Point",[58,59],114.0683,22.54554,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":64,"phoneExt":30,"email":65},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100641091","phase-1-dual-target-cspg4gd2-car-nk-cells-for-advanced-melanoma-100641091",false,"NCT07627698","Dual-Target CSPG4\u002FGD2 CAR-NK Cells for Advanced Melanoma","An Open-Label, Multicenter Phase 1\u002F2 Study of Allogeneic Dual-Target CSPG4\u002FGD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma","DUET-MEL","Inclusion Criteria:\n\n* Age 18-75 years at consent.\n* Histologically confirmed unresectable\u002Fmetastatic cutaneous melanoma or metastatic uveal melanoma.\n* Disease progression after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit. For cutaneous melanoma: prior anti-PD-1\u002FL1 (with or without antiCTLA-4) unless contraindicated; if BRAF V600-mutant, prior BRAF\u002FMEK inhibitor therapy or documented unsuitability. For uveal melanoma: prior tebentafusp if HLA-A\\*02:01-positive and eligible, or documented unsuitability\u002Funavailability plus at least one prior systemic therapy.\n* Tumor demonstrates CSPG4 and\u002For GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable tumor cells by IHC or equivalent validated assay).\n* At least 1 measurable lesion by RECIST v1.1.\n* ECOG performance status 0-1.\n* Adequate bone marrow, renal, hepatic, cardiac, and pulmonary function per protocol.\n* Life expectancy of at least 12 weeks.\n* Treated, stable brain metastases are allowed if neurologically stable for at least 4 weeks and not requiring escalating corticosteroids.\n* Willingness to use effective contraception and comply with protocol-required visits, blood sampling, and requested biopsies.\n\nExclusion Criteria:\n\n* Active symptomatic CNS metastases, leptomeningeal disease, or uncontrolled seizure disorder.\n* Prior allogeneic stem cell transplant or solid organ transplant; prior gene-modified cellular therapy within 12 weeks; or anti-cancer therapy too close to lymphodepletion per protocol washout rules.\n* Requirement for systemic immunosuppression greater than 10 mg prednisone equivalent\u002Fday or uncontrolled autoimmune\u002Finflammatory disease requiring systemic treatment.\n* Active uncontrolled infection, including uncontrolled HIV, HBV, or HCV, or fever\u002Fsepsis at the time lymphodepletion would begin.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, recent myocardial infarction, or uncontrolled thromboembolic disease.\n* Grade 2 or higher unresolved toxicities from prior therapy, except stable endocrinopathy, alopecia, or vitiligo.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or CAR-NK infusion unsafe.","ALL","18 Years","75 Years",{"count":80,"type":81},36,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This is a first-in-human, open-label, multicenter phase 1\u002F2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4\u002FGD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy",[88,89,90],"Unresectable Melanoma","Metastatic Cutaneous Melanoma","Metastatic Uveal Melanoma",[92,93,94,95,96,97,98,99,100],"CAR-NK","allogeneic NK cells","CSPG4","GD2","advanced melanoma","uveal melanoma","cell therapy","biomarker-guided","solid tumor","2026-05-31",{"date":103,"type":104},"2026-06-04","ACTUAL",{"date":106,"type":104},"2026-03-02",{"date":108,"type":81},"2028-06-17",{"name":5,"class":6},1]