[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553320":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":69,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":24,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NW-301V","EXPERIMENTAL","NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation",[13],"Drug: NW-301V",{"label":15,"type":10,"description":16,"interventionNames":17},"NW-301D","NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation",[18],"Drug: NW-301D",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","TCR-T cell targeting KRAS G12V mutation",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"TCR-T cell targeting KRAS G12D mutation",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Rui Liu","CONTACT","15377559472","rui.liu@neowisebio.com",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"Yuhui He","13820064975","yuhui.he@neowisebio.com",[39,56],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Wuhan Union Hospital","RECRUITING","Wuhan","Hubei","430022","China","CN",{"type":48,"coordinates":49},"Point",[50,51],114.26667,30.58333,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":24,"phoneExt":24,"email":24},"ZhenYu Lin",{"facility":40,"status":41,"city":42,"state":43,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":48,"coordinates":58},[50,51],{"lat":51,"lon":50},[61,65],{"name":62,"role":31,"phone":63,"phoneExt":24,"email":64},"Tao Zhang, MD, PHD","862785871982","1277577866@qq.com",{"name":66,"role":31,"phone":67,"phoneExt":24,"email":68},"Zhenyu Lin, MD","15827130393","tojilin@gmail.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Tao Zhang","Director",[74],{"name":75,"class":76},"Neowise Biotechnology","INDUSTRY","100553320","phase-1-t-cell-receptor-gene-engineered-t-cell-therapy-targeting-kras-mutations-in-the-treatment-of-subjects-with-advanced-solid-tumor-100553320",false,"NCT06484556","T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","Key Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments\n* HLA-A\\*11:01positive\n* Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation\n* Adequate organ function prior to apheresis and lymphodepleting chemotherapy\n* ECOG performance status of 0-1\n* At least one tumor lesion measurable according to RECIST 1.1\n\n(Additional protocol-defined Inclusion criteria may apply.)\n\nKey Exclusion Criteria:\n\n* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\n* Have symptomic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Active infections with HIV, HBV, HCV, or syphilis\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Exclusion criteria may apply.)","ALL","18 Years","75 Years",{"count":88,"type":89},9,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics\u002Fpharmacodynamic (PK\u002FPD) of NW-301V and NW-301D in subjects with advanced solid tumor.",[95],"Tumor, Solid","2025-07-27",{"date":98,"type":99},"2025-07-31","ACTUAL",{"date":101,"type":99},"2024-06-19",{"date":103,"type":89},"2027-06-30",{"name":71,"class":6},2]