[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629864":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":28,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":28,"id":62,"slug":28,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":28,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"DLL3\u002FCD56 Dual-Target CAR-NK (EB-DART-NK01)","EXPERIMENTAL","Allogeneic dual-target CAR-NK cells targeting DLL3 and CD56 (NCAM1) following lymphodepleting chemotherapy.",[13,14],"Biological: EB-DART-NK01 (DLL3\u002FCD56 CAR-NK cells)","Drug: Lymphodepleting chemotherapy",{"label":16,"type":10,"description":17,"interventionNames":18},"DLL3\u002FGD2 Dual-Target CAR-NK (EB-DART-NK02)","Allogeneic dual-target CAR-NK cells targeting DLL3 and GD2 following lymphodepleting chemotherapy.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"CD56\u002FGD2 Dual-Target CAR-NK (EB-DART-NK03)","Allogeneic dual-target CAR-NK cells targeting CD56 (NCAM1) and GD2 following lymphodepleting chemotherapy",[13,14],[24,29],{"type":25,"name":26,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","EB-DART-NK01 (DLL3\u002FCD56 CAR-NK cells)",[20,9,16],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Lymphodepleting chemotherapy","(fludarabine + cyclophosphamide)",[20,9,16],[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":50,"coordinates":51},"Point",[52,53],114.0683,22.54554,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":28,"email":59},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":61,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100629864",false,"NCT07480213","Adaptive Phase 1\u002F2 Study of Dual-Target CAR-NK Cells in Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC)","A Phase 1\u002F2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and\u002For GD2 in Adults With Relapsed\u002FRefractory Small Cell Lung Cancer","DART-NK-SCLC","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated).\n* At least one measurable lesion per RECIST v1.1.\n* ECOG performance status 0 to 1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \\>= 1.0 x10\\^9\u002FL, platelets \\>= 75 x10\\^9\u002FL, creatinine clearance \\>= 50 mL\u002Fmin, AST\u002FALT \\\u003C= 3 x ULN, total bilirubin \\\u003C= 1.5 x ULN).\n* Life expectancy \\>= 12 weeks.\n* Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56\u002FNCAM1, GD2).\n* Negative pregnancy test for persons of childbearing potential; agreement to use effective contraception for the protocol-defined duration.\n\nExclusion Criteria:\n\n* Active or uncontrolled CNS metastases or leptomeningeal disease (treated\u002Fstable CNS metastases may be allowed per protocol).\n* Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months (or any prior therapy directed against the investigational target antigens if it would confound safety\u002Fefficacy assessment).\n* Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease.\n* Active uncontrolled infection, including uncontrolled HIV, active hepatitis B or C with viremia, or active tuberculosis.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF \\\u003C 45%).\n* Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use \\> 10 mg\u002Fday prednisone equivalent (unless for physiologic replacement).\n* Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers).\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance.","ALL","18 Years","75 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","This study is an open-label, multi-center, adaptive Phase 1\u002F2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3\u002FCD56, DLL3\u002FGD2, and CD56\u002FGD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).",[81,82,83],"Small Cell Lung Cancer (SCLC)","Relapsed\u002FRefractory SCLC","SCLC, Extensive Stage",[85,86,87,88,89,90,91,92,93,94],"CAR-NK","dual-target","DLL3","CD56","NCAM1","GD2","adoptive cell therapy","mmunotherapy","solid tumor","small cell lung cance","2026-03-14",{"date":97,"type":98},"2026-03-18","ACTUAL",{"date":100,"type":98},"2026-02-02",{"date":102,"type":74},"2028-04-17",{"name":5,"class":6},1]