[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630316":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":50,"centralContacts":51,"locations":57,"responsibleParty":77,"collaborators":50,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":50,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":60,"whyStopped":50,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation (Part A)","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 (EB-DT-CAR-NK)","Drug: Lymphodepleting chemotherapy","Other: Supportive care",{"label":17,"type":10,"description":18,"interventionNames":19},"Expansion Cohort A (HER2\u002FMUC1)","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\u002FROR1)","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 (MUC1\u002FROR1; TNBC)","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],[29,36,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Dual-target CAR-NK cells (EB-DT-CAR-NK)","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],[35],"EB-DT-CAR-NK (Essen Biotech Dual-Target CAR-NK)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Lymphodepleting chemotherapy","fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.",[9,17,21,25],[42],"Fludarabine (Fludara®)",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"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],[49],"Cyclophosphamide (Cytoxan®)",null,[52],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":67,"coordinates":68},"Point",[69,70],114.0683,22.54554,{"lat":70,"lon":69},[73],{"name":74,"role":54,"phone":75,"phoneExt":50,"email":76},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":78,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100630316","phase-1-dual-target-car-nk-cells-for-advanced-breast-cancer-her2-and-tnbc-100630316",false,"NCT07486089","Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and 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).","DUAL-NK-BC","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":91,"type":92},60,"ESTIMATED","INTERVENTIONAL",[95,96],"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, and in some TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.",[99,100,101],"Breast Cancer (Locally Advanced or Metastatic)","HER2-positive Breast Cancer","Triple-Negative Breast Cancer (TNBC)",[103,104,105,106,107,108,109,110,111,112,113],"CAR-NK; dual targeting","doptive cellular immunotherapy","HER2 \u002F ERBB2","MUC1","ROR1","mesothelin","solid tumor","biomarker-guided cohort assignment","Lymphodepletion","fludarabine","cyclophosphamide","2026-03-17",{"date":116,"type":117},"2026-03-20","ACTUAL",{"date":119,"type":117},"2026-02-02",{"date":121,"type":92},"2028-03-17",{"name":5,"class":6},1]