[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632216":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":45,"locations":51,"responsibleParty":71,"collaborators":34,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":34,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Advanced\u002Fmetastatic breast cancer with measurable disease and expression of at least one target antigen (HER2, MUC1, or ROR1). Participants receive lymphodepletion followed by a single infusion of dual-target CAR-NK (construct chosen by antigen profile)",[13,14,15],"Biological: Dual-target CAR-NK cells","Drug: Lymphodepleting","Other: Supportive care",{"label":17,"type":10,"description":18,"interventionNames":19},"Expansion Cohort A","HER2-positive breast cancer (HER2 IHC 3+ or IHC 2+ with ISH amplification) with MUC1 expression; receives HER2\u002FMUC1 dual-target CAR-NK at RP2D",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Expansion Cohort B","HER2-positive breast cancer or HER2-low disease with high ROR1 expression; receives HER2\u002FROR1 dual-target CAR-NK at RP2D.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Expansion Cohort C","Triple-negative breast cancer with MUC1 and\u002For ROR1 expression; receives MUC1\u002FROR1 dual-target CAR-NK at RP2D. Exploratory TNBC sub-cohort: mesothelin-positive TNBC may be analyzed separately.",[13,14,15],[29,35,40],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Dual-target CAR-NK cells","Route: IV infusion. Schedule: single infusion on Day 0; optional second infusion on Day 7 in the absence of dose-limiting toxicity (DLT) and with adequate clinical status.",[9,17,21,25],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"DRUG","Lymphodepleting","chemotherapy - fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.",[9,17,21,25],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":34},"OTHER","Supportive care","Premedication per institutional standard (e.g., acetaminophen and antihistamine).\n\nTumor lysis and infection prophylaxis per institutional guidelines.",[9,17,21,25],[46],{"name":47,"role":48,"phone":49,"phoneExt":34,"email":50},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":61,"coordinates":62},"Point",[63,64],114.0683,22.54554,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":69,"phoneExt":34,"email":70},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":72,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","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":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88,89],"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.",[92,93,94],"Breast Cancer (Advanced\u002FMetastatic)","HER2-positive Breast Cancer","Triple-negative Breast Cancer",[96,97,98,99,100,101,102,103,104,105,106,107],"CAR-NK","Dual targeting","Adoptive cellular immunotherapy","HER2 (ERBB2)","MUC1","ROR1","Mesothelin","Solid tumor","Biomarker-guided cohort assignment","Lymphodepletion","Fludarabine","Cyclophosphamide","2026-03-31",{"date":110,"type":111},"2026-04-06","ACTUAL",{"date":113,"type":111},"2026-02-02",{"date":115,"type":85},"2028-04-17",{"name":5,"class":6},1]