[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523465":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":76,"collaborators":78,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":41,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":41,"enrollmentInfo":94,"targetDuration":41,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":58,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chimeric Antigen Receptors","EXPERIMENTAL","blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.",[13,14,15],"Drug: Cyclophosphamide","Drug: Fludarabine","Biological: Cell Therapy",[17,29,36],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cyclophosphamide","cyclophosphamide 300 mg\u002Fmeter square IV",[9],[23,24,25,26,27,28],"Cycloblastin","Cytoxan","Endoxan","Neosar","Procytox","Revimmune",{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Fludarabine","fludarabine 30 mg\u002Fmeter square IV × 3 days",[9],[34,35],"Fludara","Fludarabine Phosphate",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BIOLOGICAL","Cell Therapy","the autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen iC9-CAR.CSPG4 T cell infusion iC9-CAR.CSPG4 T cell infusion",[9],null,[43],{"name":44,"affiliation":5,"role":45},"Jared Weiss, MD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},"Catherine Cheng","CONTACT","+1 919-445-4208","UNCImmunotherapy@med.unc.edu",{"name":53,"role":49,"phone":54,"phoneExt":41,"email":51},"Spencer SB Laing","+1 919-445-4175",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-79.05584,35.9132,{"lat":68,"lon":67},[71,73,75],{"name":44,"role":49,"phone":72,"phoneExt":41,"email":51},"919-843-7718",{"name":74,"role":49,"phone":41,"phoneExt":41,"email":51},"Lauren Higgins",{"name":44,"role":45,"phone":41,"phoneExt":41,"email":41},{"type":77,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[79,82],{"name":80,"class":81},"Bellicum Pharmaceuticals","INDUSTRY",{"name":83,"class":84},"National Cancer Institute (NCI)","NIH","100523465","phase-1-autologous-car-t-cells-targeting-cspg4-in-relapsedrefractory-hnscc-100523465",false,"NCT06096038","Autologous CAR-T Cells Targeting CSPG4 in Relapsed\u002FRefractory HNSCC","Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.","ALL","18 Years",{"count":95,"type":96},33,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE1","PHASE2","The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.",[103,104,105,106],"Head and Neck Cancer","Relapse","Recurrent","Refractory Cancer",[108],"cellular therapy","2026-02-18",{"date":111,"type":112},"2026-02-20","ACTUAL",{"date":114,"type":112},"2024-04-05",{"date":116,"type":96},"2028-08-01",{"name":5,"class":6},1]