[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553338":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":56,"collaborators":60,"id":64,"slug":24,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":24,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","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 T cell targeting KRAS G12V mutation",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"TCR-T T cell targeting KRAS G12D mutation",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Rui Liu","CONTACT","0512-67991566","rui.liu@neowisebio.com",{"name":35,"role":31,"phone":32,"phoneExt":24,"email":36},"Yuhui He","yuhui.he@neowisebio.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.17667,39.14222,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":53,"phoneExt":54,"email":55},"Ting Deng, MD","022-23340123","1053","xymcdengting@126.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Ting Deng","Director",[61],{"name":62,"class":63},"Neowise Biotechnology","INDUSTRY","100553338",false,"NCT06484790","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-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation \\* 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 (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\\* 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 (Additional protocol-defined Exclusion criteria may apply.)","ALL","18 Years","75 Years",{"count":74,"type":75},9,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Tumor, Solid","2025-11-19",{"date":84,"type":85},"2025-11-25","ACTUAL",{"date":87,"type":85},"2024-04-08",{"date":89,"type":75},"2027-04-07",{"name":58,"class":6},1]