[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-locally-advanced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-locally-advanced":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":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":5},"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":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29,30,31],"Pancreatic Ductal Adenocarcinoma (PDAC)","Unresectable Locally Advanced","Metastatic Disease",[33,34,35,36,37,38,39,40,41,42,43,44],"Pancreatic cancer","PDAC","CAR-NK","Natural killer cells","Mesothelin","MSLN","MUC1","Claudin 18.2","CLDN18.2","Adoptive cell therapy","Immunotherapy","Biomarker-guided","RECRUITING","2026-05-31",{"date":48,"type":49},"2026-06-04","ACTUAL",{"date":51,"type":49},"2026-03-02",{"date":53,"type":22},"2028-03-17",{"name":55,"class":56},"Beijing Biotech","INDUSTRY"]