[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638978":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":25,"centralContacts":29,"locations":7,"responsibleParty":35,"collaborators":7,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":7,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":7,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":56,"locationsCount":7},{"fullName":5,"class":6},"Providence Health & Services","OTHER",null,[9,16,21],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Cyclophosphamide","Patients will receive 300 mg\u002Fm2\u002Fday IV cyclophosphamide as part of a conditioning regimen on Days -6 to -4.",[14,15],"Cytoxan","Cy",{"type":10,"name":17,"description":18,"armGroupLabels":7,"otherNames":19},"Fludarabine","Patients will receive 30 mg\u002Fm2\u002Fday fludarabine as part of a conditioning regimen on Days -6 to -4.",[20],"Fludara",{"type":22,"name":23,"description":24,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","Cell infusion","Cells will be administered at a dose of between 1x109 to 1x1010 TCR-T cells. If manufactured product does not meet target range, product may still be administered with Investigator discretion.",[26],{"name":27,"affiliation":5,"role":28},"Binbin Zheng, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":7,"email":34},"Kim Sutcliffe, RN","CONTACT","503-215-1979","canrsrchstudies@providence.org",{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100638978","intermediate-size-ind-for-treatment-of-patients-with-advanced-cancer-using-t-cells-engineered-to-express-tcr-targeting-mutant-kras-100638978",false,"NCT07614048","Intermediate-size IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express TCR Targeting Mutant KRAS","Intermediate-size Patient Population IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express T-cell Receptors (TCR) Targeting Mutant KRAS","Inclusion Criteria:\n\n* Histologically confirmed, advanced or metastatic solid tumor with a documented KRAS G12D mutation confirmed by a CLIA-certified assay, and a high-resolution HLA typing demonstrating expression of HLA-A11:01 and\u002For HLA-C08:02.\n* Disease-specific prior therapy requirements:\n\n  1. Advanced colorectal cancer: prior treatment with fluoropyrimidine-based chemotherapy regimens with exposure to both oxaliplatin and irinotecan.\n  2. Advanced pancreatic ductal adenocarcinoma: prior treatment with at least one systemic regimen, including either a fluoropyrimidine-based regimen (e.g., FOLFIRINOX), or a gemcitabine-based regimen (gemcitabine with nab-paclitaxel, or gemcitabine with cisplatin).\n  3. Advanced non-small cell lung cancer: prior receipt of at least one line of therapy including a PD-1 or PD-L1 inhibitor, with or without platinum-based chemotherapy.\n  4. Advanced esophageal\u002Fgastroesophageal\u002Fgastric adenocarcinoma: patients are required to have received at least one line of fluoropyrimidine-based chemotherapy. For tumors harboring HER2 amplifications, prior treatment with at least one HER2-targeted therapy is required. For tumors with combined positive score (CPS) or 1 or higher, prior treatment with immune checkpoint inhibitor is required.\n  5. Advanced small bowel adenocarcinoma: patients are required to have received fluoropyrimidine-based chemotherapy regimens containing oxaliplatin and irinotecan.\n  6. Advanced appendiceal adenocarcinoma: patients are required to have received fluoropyrimidine-based chemotherapy regimens containing oxaliplatin and irinotecan.\n  7. Advanced biliary tract adenocarcinoma and periampullary adenocarcinoma: patients are required to have received at least one prior line of therapy. For tumors with FGFR2 fusions, a prior exposure to an FGFR inhibitor is required.","ALL","18 Years","EXPANDED_ACCESS","The goal of this intermediate-size expanded access treatment program is to treat a subset of patients with advanced solid cancers, specifically pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), that express KRAS-G12D and the appropriate HLA with adoptive t-cell therapy.\n\nParticipants will provide leukapheresis product which will be processed and generated in our facility. The participant's peripheral blood T cells will be stimulated and then transduced with GMP-grade retroviral vectors encoding KRAS-G12D-neoantigen reactive TCR. On Days -6 to -4, the participant will receive outpatient chemotherapy as a preparative regimen. On Day 0, participant will receive cell product infusion as an inpatient procedure. Following infusion, participant will receive supportive care through discharge.",[49,50],"PDAC - Pancreatic Ductal Adenocarcinoma","Colorectal Cancer","AVAILABLE","2026-07-21",{"date":54,"type":55},"2026-07-23","ACTUAL",{"name":5,"class":6}]