[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643105":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":41,"locations":47,"responsibleParty":67,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"EB-DuoNK-MSLN\u002FEGFR","EXPERIMENTAL","Participants with tumors co-expressing MSLN and EGFR (meeting screening thresholds) receive lymphodepletion followed by EB-DuoNK-MSLN\u002FEGFR infusion at the assigned dose leve",[13,14,15],"Biological: Dual-target CAR-NK cells","Drug: Lymphodepleting chemotherapy","Other: Supportive care",{"label":17,"type":10,"description":18,"interventionNames":19},"EB-DuoNK-MSLN\u002FHER2","Participants with tumors co-expressing MSLN and HER2\u002FERBB2 receive lymphodepletion followed by EB-DuoNK-MSLN\u002FHER2 infusion at the assigned dose level.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"EB-DuoNK-EGFR\u002FHER2","Participants with tumors co-expressing EGFR and HER2\u002FERBB2 receive lymphodepletion followed by EB-DuoNK-EGFR\u002FHER2 infusion at the assigned dose level.",[13,14,15],[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Dual-target CAR-NK cells","Allogeneic cord-blood-derived NK cells engineered to express a dual-target CAR (tandem OR-gate) and IL-15 for enhanced persistence; includes an inducible safety switch . Infused intravenously on Day 1",[21,9,17],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Lymphodepleting chemotherapy","Fludarabine + Cyclophosphamide administered on Days -5, -4, and -3 prior to CAR-NK infusion",[21,9,17],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"OTHER","Supportive care","Premedication and management per institutional guidelines (e.g., acetaminophen\u002Fantihistamine pre-infusion; tocilizumab and corticosteroids per CRS\u002FICANS management algorithm).",[21,9,17],[42],{"name":43,"role":44,"phone":45,"phoneExt":30,"email":46},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":57,"coordinates":58},"Point",[59,60],114.0683,22.54554,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":65,"phoneExt":30,"email":66},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100643105","phase-1-dual-target-car-nk-cells-targeting-msln-egfr-or-her2-in-advanced-nsclc-100643105",false,"NCT07641023","Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC","A Phase 1\u002F2, Open-label, Biomarker-guided Study of Dual-target Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Targeting Mesothelin (MSLN) With EGFR or HER2\u002FERBB2, or EGFR With HER2\u002FERBB2, in Participants With Advanced\u002FMetastatic Non-small Cell Lung Cancer (NSCLC)","DUO-NK-NSCLC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB\u002FIIIC or Stage IV, with radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate).\n* At least one measurable lesion per RECIST v1.1.\n* Archival tumor tissue available (or willingness to undergo a fresh biopsy) for antigen testing.\n* Tumor co-expression of at least two of the following antigens at screening: MSLN, EGFR, HER2\u002FERBB2.\n\nExample thresholds: IHC ≥2+ in ≥50% of tumor cells for each required antigen (or an equivalent RNA expression threshold).\n\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, hepatic, renal) as defined by protocol laboratory limits.\n* Life expectancy ≥12 weeks.\n* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception for the study-defined period.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled central nervous system (CNS) metastases. Participants with previously treated\u002Fstable CNS disease may be eligible if clinically stable and off high-dose corticosteroids.\n* Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.\n* History of severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior therapies.\n* Clinically significant interstitial lung disease or pneumonitis requiring systemic steroids, or uncontrolled pulmonary comorbidity that would confound toxicity monitoring.\n* Active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).\n* Active uncontrolled infection, including uncontrolled HIV, active hepatitis B, or active hepatitis C infection.\n* Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or LVEF below institutional lower limit).\n* Pregnant or breastfeeding.\n* Concurrent anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy) within protocol-defined washout periods.\n* Any condition that, in the investigator's opinion, would interfere with participant safety or compliance","ALL","18 Years","75 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This is a two-part, biomarker-guided Phase 1\u002F2 study evaluating the safety, feasibility, and preliminary anti-tumor activity of off-the-shelf dual-target CAR-NK cells in participants with advanced or metastatic NSCLC whose tumors co-express at least two of the following antigens: Mesothelin (MSLN), EGFR, and HER2\u002FERBB2.\n\nParticipants will receive lymphodepleting chemotherapy followed by infusion of the CAR-NK product matched to their tumor antigen profile. A data-driven interim assessment will be used to select the most suitable construct for expansion.",[89,90],"Non-Small Cell Lung Cancer","Advanced\u002FMetastatic",[92,93,94,95,96,97,98,99,100,101,102],"CAR-NK","Dual-target","Bispecific","Adoptive cell therapy","Solid tumor","Immunotherapy","Biomarker-guided","Mesothelin","EGFR","HER2","Dose escalation","2026-06-06",{"date":105,"type":106},"2026-06-11","ACTUAL",{"date":108,"type":106},"2026-03-02",{"date":110,"type":82},"2028-06-17",{"name":5,"class":6},1]