[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100629864","phase-1-adaptive-phase-12-study-of-dual-target-car-nk-cells-in-relapsedrefractory-small-cell-lung-cancer-sclc-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":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"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).",[29,30,31],"Small Cell Lung Cancer (SCLC)","Relapsed\u002FRefractory SCLC","SCLC, Extensive Stage",[33,34,35,36,37,38,39,40,41,42],"CAR-NK","dual-target","DLL3","CD56","NCAM1","GD2","adoptive cell therapy","mmunotherapy","solid tumor","small cell lung cance","RECRUITING","2026-03-14",{"date":46,"type":47},"2026-03-18","ACTUAL",{"date":49,"type":47},"2026-02-02",{"date":51,"type":22},"2028-04-17",{"name":53,"class":54},"Beijing Biotech","INDUSTRY"]