[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-advancedmetastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-advancedmetastatic":28},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100632216","phase-1-dual-target-car-nk-cells-for-advanced-breast-cancer-her2-tnbc-100632216",false,"NCT07510802","Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC","Phase 1\u002F2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2\u002FERBB2, MUC1, and\u002For ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).","Inclusion Criteria:\n\n* Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.\n* Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).\n* Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.\n* At least one measurable lesion per RECIST v1.1.\n* Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2\u002FERBB2, MUC1, or ROR1). For TNBC, mesothelin assessment may be performed for exploratory analyses.\n* ECOG performance status 0-1.\n* Adequate organ function (example thresholds): ANC ≥ 1.0 x 10\\^9\u002FL; platelets ≥ 75 x 10\\^9\u002FL; hemoglobin\n\n  * 8 g\u002FdL; AST\u002FALT ≤ 3x ULN (≤ 5x with liver metastases); total bilirubin ≤ 1.5x ULN; creatinine clearance\n  * 50 mL\u002Fmin.\n* Left ventricular ejection fraction (LVEF) ≥ 45% and no uncontrolled cardiac arrhythmia.\n* Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception during study treatment and for 6 months after last CAR-NK infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.\n* Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.\n* Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).\n* Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).\n* History of severe hypersensitivity to fludarabine or cyclophosphamide.\n* Pregnant or breastfeeding.\n* Concurrent participation in another interventional study that could confound safety or efficacy assessments.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study (e.g., uncontrolled comorbidity, inability to comply with protocol procedures).","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2\u002FERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.",[28,29,30],"Breast Cancer (Advanced\u002FMetastatic)","HER2-positive Breast Cancer","Triple-negative Breast Cancer",[32,33,34,35,36,37,38,39,40,41,42,43],"CAR-NK","Dual targeting","Adoptive cellular immunotherapy","HER2 (ERBB2)","MUC1","ROR1","Mesothelin","Solid tumor","Biomarker-guided cohort assignment","Lymphodepletion","Fludarabine","Cyclophosphamide","RECRUITING","2026-03-31",{"date":47,"type":48},"2026-04-06","ACTUAL",{"date":50,"type":48},"2026-02-02",{"date":52,"type":21},"2028-04-17",{"name":54,"class":55},"Beijing Biotech","INDUSTRY"]