[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-sclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-sclc":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"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).",[28,29,30],"Small Cell Lung Cancer (SCLC)","Relapsed\u002FRefractory SCLC","SCLC, Extensive Stage",[32,33,34,35,36,37,38,39,40,41],"CAR-NK","dual-target","DLL3","CD56","NCAM1","GD2","adoptive cell therapy","mmunotherapy","solid tumor","small cell lung cance","RECRUITING","2026-03-14",{"date":45,"type":46},"2026-03-18","ACTUAL",{"date":48,"type":46},"2026-02-02",{"date":50,"type":21},"2028-04-17",{"name":52,"class":53},"Beijing Biotech","INDUSTRY",""]