[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053502":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":72,"collaborators":74,"id":80,"slug":46,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":46,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":46,"enrollmentInfo":88,"targetDuration":46,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":54,"whyStopped":46,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"iC9-CAR.B7-H3 T cells","EXPERIMENTAL","Specimen will be collected to prepare the iC9-CAR.B7-H3 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9-CAR.B7-H3 T cells. In part 2, the iC9-CAR.B7-H3 T cells are given by infusion after completion of lymphodepletion chemotherapy.",[13,14,15],"Biological: iC9-CAR.B7-H3 T Cell Therapy","Drug: cyclophosphamide","Drug: fludarabine",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","iC9-CAR.B7-H3 T Cell Therapy","iC9-CAR.B7-H3 T cells will then be administered intravenously",[9],[9],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","cyclophosphamide","cyclophosphamide 300 mg\u002Fm2 IV will be given.",[9],[29],"Cytoxan",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"fludarabine","fludarabine 30 mg\u002Fm2 IV will be given.",[9],[35,36],"Fludara","Fludarabine Phosphate",[38],{"name":39,"affiliation":5,"role":40},"Yara E Abdou, MD","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Caroline Babinec","CONTACT","919-445-4208",null,"UNCImmunotherapy@med.unc.edu",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":47},"Catherine Cheng","+1 919-445-4208",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of North Carolina","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-79.05584,35.9132,{"lat":64,"lon":63},[67,69],{"name":49,"role":44,"phone":45,"phoneExt":46,"email":68},"catherine_cheng@med.unc.edu",{"name":70,"role":71,"phone":46,"phoneExt":46,"email":46},"E. Claire Dees, MD, MSc","SUB_INVESTIGATOR",{"type":73,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[75,78],{"name":76,"class":77},"National Cancer Institute (NCI)","NIH",{"name":79,"class":6},"M.D. Anderson Cancer Center","100053502",false,"NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1","ALL","18 Years",{"count":89,"type":90},42,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[96,97,98,99],"Breast Cancer","Relapse","Resistant Cancer","Triple Negative Breast Cancer",[101,102],"cellular therapy","biologic therapy","2026-07-09",{"date":105,"type":106},"2026-07-13","ACTUAL",{"date":108,"type":106},"2024-06-27",{"date":110,"type":90},"2030-05",{"name":5,"class":6},1]