[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650321":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":29,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":29,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":44,"whyStopped":29,"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","EXPERIMENTAL","Allogeneic dual-target CAR-NK cells targeting DLL3 and CD56 (NCAM1) following lymphodepleting chemotherapy.",[13,14],"Biological: EB-DART-NK01","Drug: Lymphodepleting chemotherapy",{"label":16,"type":10,"description":17,"interventionNames":18},"DLL3\u002FGD2 Dual-Target CAR-NK","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","Allogeneic dual-target CAR-NK cells targeting CD56 (NCAM1) and GD2 following lymphodepleting chemotherapy.",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","EB-DART-NK01","Allogeneic dual-target CAR-NK cells engineered to enhance tumor recognition and cytotoxicity against heterogeneous solid tumors.",[20,9,16],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Lymphodepleting chemotherapy","An alkylating chemotherapy agent used as part of lymphodepleting conditioning prior to CAR-NK cell infusion to enhance cell expansion, persistence, and anti-tumor activity.",[20,9,16],[36],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.0683,22.54554,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":29,"email":60},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":62,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100650321","phase-1-adaptive-phase-12-study-of-dual-target-car-nk-cells-in-relapsedrefractory-small-cell-lung-cancer-sclc-100650321",false,"NCT07744256","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","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":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","This example 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).",[82,83,84],"Small Cell Lung Cancer (SCLC)","Relapsed\u002FRefractory SCLC","Extensive-stage SCLC",[86,87,88,89,90,91,92,93,94],"CAR-NK","Dual-target","Adoptive cell therapy","Immunotherapy","Solid tumor","Small cell lung cancer","DLL3","CD56 (NCAM1)","GD2","2026-07-30",{"date":97,"type":98},"2026-08-04","ACTUAL",{"date":100,"type":98},"2026-03-02",{"date":102,"type":75},"2028-03-17",{"name":5,"class":6},1]