[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604125":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":37,"locations":46,"responsibleParty":188,"collaborators":28,"id":190,"slug":191,"hasResults":192,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":28,"eligibilityCriteria":196,"healthyVolunteers":192,"sex":197,"minAge":198,"maxAge":28,"enrollmentInfo":199,"targetDuration":28,"studyType":202,"phases":203,"briefSummary":206,"conditions":207,"keywords":28,"overallStatus":49,"whyStopped":28,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Anocca AB","OTHER_GOV",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ANOC-001","OTHER","Treatment",[13],"Biological: ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)",{"label":15,"type":10,"description":11,"interventionNames":16},"ANOC-002",[17],"Biological: ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)",{"label":19,"type":10,"description":11,"interventionNames":20},"ANOC-003",[21],"Biological: ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)",[23,29,33],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)","The cells will be gene edited and administered by a single IV infusion on Day 1.\n\nDrugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)","The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.",[15],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)","The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy",[19],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":28,"email":42},"Amu Wang","CONTACT","+46703784946","amu.wang@anocca.com",{"name":5,"role":40,"phone":44,"phoneExt":28,"email":45},"+46841080701","clinical.trials@anocca.com",[47,64,79,92,105,119,132,145,160,173],{"facility":48,"status":49,"city":50,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Herlev and Gentofte University Hospital","RECRUITING","Copenhagen","Denmark","DK",{"type":54,"coordinates":55},"Point",[56,57],12.56553,55.67594,{"lat":57,"lon":56},[60],{"name":61,"role":40,"phone":62,"phoneExt":28,"email":63},"Inna Chen","+45 38682898","inna.chen@regionh.dk",{"facility":65,"status":49,"city":66,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Charité Universitätsmedizin Berlin","Berlin","Germany","DE",{"type":54,"coordinates":70},[71,72],13.41053,52.52437,{"lat":72,"lon":71},[75],{"name":76,"role":40,"phone":77,"phoneExt":28,"email":78},"Antonia Busse","+49 30450513567","antonia.busse@charite.de",{"facility":80,"status":49,"city":81,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus","Dresden",{"type":54,"coordinates":83},[84,85],13.73832,51.05089,{"lat":85,"lon":84},[88],{"name":89,"role":40,"phone":90,"phoneExt":28,"email":91},"Martin Wermke","+49 351 458-7566","Martin.Wermke@ukdd.de",{"facility":93,"status":49,"city":94,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Universitaetsklinikum Heidelberg","Heidelberg",{"type":54,"coordinates":96},[97,98],8.69079,49.40768,{"lat":98,"lon":97},[101],{"name":102,"role":40,"phone":103,"phoneExt":28,"email":104},"Christoph Springfeld","+49 6221 56 5615","christoph.springfeld@med.uni-heidelberg.de",{"facility":106,"status":107,"city":108,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Universitaetsklinikum Leipzig - Universitaeren Krebszentrum (UCCL)","NOT_YET_RECRUITING","Leipzig",{"type":54,"coordinates":110},[111,112],12.37129,51.33962,{"lat":112,"lon":111},[115],{"name":116,"role":40,"phone":117,"phoneExt":28,"email":118},"Albrecht Hoffmeister","+493419712240","albrecht.hoffmeister@medizin.uni-leipzig.de",{"facility":120,"status":107,"city":121,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III","München",{"type":54,"coordinates":123},[124,125],13.31243,51.60698,{"lat":125,"lon":124},[128],{"name":129,"role":40,"phone":130,"phoneExt":28,"email":131},"Lena Weiss","+4915257906966","Lena.Weiss@med.uni-muenchen.de",{"facility":133,"status":49,"city":134,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"University Hospital and Faculty of Medicine Eberhard Karls University Tübingen","Tübingen",{"type":54,"coordinates":136},[137,138],9.05222,48.52266,{"lat":138,"lon":137},[141],{"name":142,"role":40,"phone":143,"phoneExt":28,"email":144},"Wolfgang Bethge","+49 (0)7071 29-87121","wolfgang.bethge@med.uni-tuebingen.de",{"facility":146,"status":49,"city":147,"state":28,"zip":28,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Amsterdam UMC - VU Medical Center","Amsterdam","Netherlands","NL",{"type":54,"coordinates":151},[152,153],4.88969,52.37403,{"lat":153,"lon":152},[156],{"name":157,"role":40,"phone":158,"phoneExt":28,"email":159},"Johanna Willemijn Wilmink","+31(0)204444321","j.w.wilmink@amsterdamumc.nl",{"facility":161,"status":49,"city":162,"state":28,"zip":28,"country":148,"countryCode":149,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Radboud University Medical Center","Nijmegen",{"type":54,"coordinates":164},[165,166],5.85278,51.8425,{"lat":166,"lon":165},[169],{"name":170,"role":40,"phone":171,"phoneExt":28,"email":172},"Ingrid M.E. Desar","+31 243610353","Ingrid.Desar@radboudumc.nl",{"facility":174,"status":49,"city":175,"state":28,"zip":28,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Karolinska University Hospital","Stockholm","Sweden","SE",{"type":54,"coordinates":179},[180,181],18.06871,59.32938,{"lat":181,"lon":180},[184],{"name":185,"role":40,"phone":186,"phoneExt":28,"email":187},"Maximiliam Kordes","08-123-83611","maximilian.kordes@regionstockholm.se",{"type":189,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100604125","phase-1-master-protocol-of-tcr-modified-t-cell-therapy-targeting-hla-restricted-kras-antigen-administered-in-adult-patients-with-metastatic-or-locally-advanced-pdac-100604125",false,"NCT07145450","Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC","Phase 1\u002F2 Master Protocol for Open-Label, Multi-Centre, Single-Arm Sub-Studies, First in Human Clinical Studies of TCR-T Therapy (Autologous TCR- Modified T-Cell Therapy) Targeting Mutated Kirsten Rat Sarcoma (mutKRAS) Administered in Metastatic or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Adult Patients With Specific mutKRAS and Human Leukocyte Antigen (HLA) Genotypes","Inclusion Criteria:\n\n1. Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.\n2. HLA genotyping confirmed with a high-resolution method.\n3. Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.\n4. Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).\n5. Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.\n6. Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT of chest\u002Fabdomen\u002Fpelvis and imaging of the affected extremity or brain, as appropriate), or magnetic resonance imaging (MRI) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast.\n\nExclusion Criteria:\n\n1. Another malignancy other than PDAC.\n2. Current or history of brain metastasis.\n3. Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.","ALL","18 Years",{"count":200,"type":201},96,"ESTIMATED","INTERVENTIONAL",[204,205],"PHASE1","PHASE2","This is an open-label, multi-centre, single-arm Phase 1\u002F2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.",[208],"PDAC","2026-06-04",{"date":211,"type":212},"2026-06-08","ACTUAL",{"date":214,"type":212},"2025-07-03",{"date":216,"type":201},"2030-07-31",{"name":5,"class":6},10]