[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637483":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":41,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":41,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":51,"whyStopped":41,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: EB-DNK101 (MSLN\u002FMUC1 Dual-CAR NK)","EXPERIMENTAL","Participants with PDAC whose tumors express MSLN and\u002For MUC1 per central IHC are assigned to Arm A.",[13,14,15],"Biological: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)","Biological: EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)","Drug: Lymphodepleting chemotherapy (Flu\u002FCy)",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B: EB-DNK102 (CLDN18.2\u002FMUC1 Dual-CAR NK)","Participants with PDAC whose tumors express CLDN18.2 and\u002For MUC1 per central IHC are assigned to Arm B.",[13,14,15],[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)","Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting MSLN and MUC1. Administered as an IV infusion on Day 0 (dose level dependent).",[9,17],[27],"MSLN\u002FMUC1 Dual-CAR NK, Dual-target CAR-NK (MSLN\u002FMUC1)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)","Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting CLDN18.2 and MUC1. Administered as an IV infusion on Day 0 (dose level dependent).",[9,17],[33],"CLDN18.2\u002FMUC1 Dual-CAR NK, Dual-target CAR-NK (CLDN18.2\u002FMUC1)",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Lymphodepleting chemotherapy (Flu\u002FCy)","fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to\n\n-4) prior to CAR-NK infusion.",[9,17],[40],"Fludarabine + Cyclophosphamide, Conditioning regimen",null,[43],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":58,"coordinates":59},"Point",[60,61],114.0683,22.54554,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":41,"email":67},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":69,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100637483","phase-1-dual-target-car-nk-cells-targeting-mesothelin-msln-and-muc1-in-advanced-pancreatic-ductal-adenocarcinoma-100637483",false,"NCT07627711","Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma","A Phase 1\u002F2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2\u002FMUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","DUAL-NK-PDAC","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Unresectable locally advanced or metastatic disease with progression after at least 1 prior standard systemic therapy regimen, or intolerance\u002Fineligibility for standard therapy.\n* At least 1 measurable lesion per RECIST v1.1.\n* Tumor antigen expression by central IHC (archival or fresh biopsy): • Arm A eligibility: MSLN positive and\u002For MUC1 positive. • Arm B eligibility: CLDN18.2 positive and\u002For MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in \\>=50% of tumor cells, or H-score above protocol-defined cutoff.)\n* ECOG performance status 0-1.\n* Adequate organ function (example): ANC \\>= 1.0 x 10\\^9\u002FL; platelets \\>= 75 x 10\\^9\u002FL; hemoglobin \\>= 8 g\u002FdL; AST\u002FALT \\\u003C= 3x ULN (\\\u003C= 5x ULN with liver metastases); total bilirubin \\\u003C= 1.5x ULN; creatinine clearance \\>= 50 mL\u002Fmin.\n* Life expectancy \\>= 12 weeks.\n* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined follow-up period.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases or carcinomatous meningitis.\n* Clinically significant uncontrolled infection (including uncontrolled bacterial, fungal, or viral infection).\n* Known active hepatitis B or hepatitis C with detectable viral load; known uncontrolled HIV infection.\n* Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Prior gene-modified cellular therapy (e.g., CAR-T\u002FCAR-NK) within 6 months or prior therapy targeting the same antigen(s) Ongoing requirement for systemic immunosuppressive therapy (e.g., chronic corticosteroids above physiologic replacement).\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, or NYHA class III\u002FIV heart failure) within a protocol-defined period.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapy allowed).\n* Pregnant or breastfeeding.\n* Any medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with safe participation or interpretation of results.","ALL","18 Years","75 Years",{"count":82,"type":83},42,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","This example study evaluates the safety, tolerability, and preliminary anti-tumor activity of investigational, dual-targeting chimeric antigen receptor natural killer (CAR-NK) cell products for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Participants are assigned to one of two biomarker-defined cohorts based on tumor antigen expression: (A) Mesothelin (MSLN) and\u002For MUC1, or (B) Claudin 18.2 (CLDN18.2) and\u002For MUC1. The study uses a dose-escalation followed by dose-expansion design to define a recommended Phase 2 dose (RP2D) and to estimate response rates in each cohort.",[90,91,92],"Pancreatic Ductal Adenocarcinoma (PDAC)","Unresectable Locally Advanced","Metastatic Disease",[94,95,96,97,98,99,100,101,102,103,104,105],"Pancreatic cancer","PDAC","CAR-NK","Natural killer cells","Mesothelin","MSLN","MUC1","Claudin 18.2","CLDN18.2","Adoptive cell therapy","Immunotherapy","Biomarker-guided","2026-05-31",{"date":108,"type":109},"2026-06-04","ACTUAL",{"date":111,"type":109},"2026-03-02",{"date":113,"type":83},"2028-03-17",{"name":5,"class":6},1]