[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373734":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":39,"locations":45,"responsibleParty":63,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":23,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":23,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TCR Transduced T cell therapy","EXPERIMENTAL","Pre-conditioning: Non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine\n\nTCR transduced T cell infusion: mutant KRAS G12V-specific TCR transduced autologous T cells (1e9\\~1e11). If the participant responds to the first infusion, the second or more infusions will be considered when the disease is progressing.\n\nAnti-PD-1 therapy: anti-PD-1 will be administered if needed.",[13,14,15,16],"Drug: Cyclophosphamide","Drug: Fludarabine","Biological: Mutant KRAS G12V-specific TCR transduced autologous T cells","Drug: Anti-PD-1 monoclonal antibody",[18,24,28,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Cyclophosphamide","Cyclophosphamide will be administered prior to cell infusion.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Fludarabine","Fludarabine will be administered prior to cell infusion.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"BIOLOGICAL","Mutant KRAS G12V-specific TCR transduced autologous T cells","After preconditioning regimen, T cells will be infused to the patient intravenously in the Patient Care Unit over approximately 30 to 50 minutes.",[9],{"type":19,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Anti-PD-1 monoclonal antibody","During the treatment, anti-PD-1 monoclonal antibody will be administered if needed.",[9],[38],"Anti-PD-1",[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Shiwei Guo, Doctor","CONTACT","+8618621500666","gestwa@163.com",[46],{"facility":5,"status":47,"city":48,"state":23,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Shanghai","200433","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59,60],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},{"name":61,"role":62,"phone":23,"phoneExt":23,"email":23},"Gang Jin, Doctor","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Guo ShiWei","Doctor","100373734","phase-1-mutant-kras-g12v-specific-tcr-transduced-t-cell-therapy-for-advanced-pancreatic-cancer-100373734",false,"NCT04146298","Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received surgery and adjuvant chemotherapy previously).\n* Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods.\n* Patients must be HLA-A\\*11:01.\n* Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in diameter.\n* Patients between 18 to 75 years old are eligible.\n* Patients should have good clinical performance status (ECOG 0 or 1).\n* Patients must practice birth control once enrolled into the study and for up to four months after therapy.\n* Patients must be seronegative for HIV antibody.\n* Patients must be seronegative for hepatitis B surface antigen and core antibody (or HBV non-detectable by QPCR).\n* Patients must be seronegative for hepatitis C antibody (or HCV non-detectable by QPCR).\n* Baseline hematology criteria:\n\n  * Absolute neutrophil count of at least 1000\u002Fmm\\^3.\n  * White blood cell count of at least 3000\u002Fmm\\^3.\n  * Platelet count of at least 100,000\u002Fmm\\^3.\n  * Hemoglobin \\> 8.0 g\u002FdL.\n* Baseline chemistry criteria:\n\n  * Serum ALT\u002FAST less than or equal to 3.0 x ULN.\n  * Total bilirubin less than or equal to 1.5 mg\u002FdL, unless the patient has Gilbert's Syndrome in which case total bilirubin must be less than or equal to 3.0 mg\u002FdL.\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n* Anticipated lifespan greater than 12 weeks.\n* Patients must be willing and able to comply with all study-related procedures and follow-up requirements.\n* Patients must be able to understand and sign a written Informed Consent Document as well as a durable power of attorney.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or HIV).\n* Patients with active systemic infections, coagulation disorders, or any other major medical illnesses.\n* Patients with concurrent opportunistic infections.\n* Patients on concurrent systemic steroid therapy.\n* Patients with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine).\n* Patients with active coronary ischemic symptoms.\n* Patients who are receiving any other investigational agents.","ALL","18 Years","75 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.",[85,86,87,88],"Pancreatic Cancer","Pancreatic Neoplasms","Pancreatic Ductal Adenocarcinoma","Advanced Cancer",[90,91,92,93],"pancreatic cancer","TCR transduced T cells","adoptive cell therapy","KRAS","2025-12-18",{"date":96,"type":97},"2025-12-24","ACTUAL",{"date":99,"type":97},"2021-10-21",{"date":101,"type":78},"2028-12",{"name":5,"class":6},1]