[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neowise Biotechnology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":5},"100660261","phase-1-phase-1-study-of-nw-301v-tcr-t-cells-in-advanced-solid-tumors-with-kras-g12v-mutation-100660261",false,"NCT07875920","Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation","A Single-Arm, Multicenter, Open-Label, Phase Ia\u002FIb Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations","Key Inclusion Criteria:\n\nApplicable to both Phase 1a and 1b:\n\n* Age between 18-75 years\n* HLA-A\\*11:01 positive\n* Tumor confirmed to have KRAS G12V mutation\n* At least one measurable lesion according to RECIST 1.1\n* ECOG 0-1\n* Life expectancy \\> 3 months before leukapheresis\n* Adequate organ functions prior to leukapheresis and lymphodepletion\n\nFor Phase 1a only:\n\n* Histologically or pathologically confirmed, advanced or unresectable solid tumors including, but not limited to, pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC), and lung adenocarcinoma (LUAD)\n* Participants must have no standard treatment options available or are unable to tolerate currently available standard treatment\n\nFor Phase 1b only:\n\n* Cohort A: Histologically or pathologically confirmed advanced or locally advanced unresectable PDAC that had failed or progressed after at least 1 line of prior systemic therapy\n* Cohort B: Histologically or pathologically confirmed advanced CRC that had failed or progressed after at least 2 lines of prior systemic therapies\n* Cohort C: Histologically or pathologically confirmed advanced LUAD that had failed or progressed after at least 1 line of prior systemic therapy\n\n(Additional protocol-defined Inclusion criteria may apply)\n\nKey Exclusion Criteria:\n\nApplicable to both Phase 1a and 1b:\n\n* Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks 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 leukapheresis or lymphodepletion\n* Have symptomatic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Inclusion criteria may apply)","ALL","18 Years","75 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single-arm, multicenter, open-label, Phase 1a\u002F1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.",[27,28,29,30,31,32,33],"Advanced Solid Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Adenocarcinoma","Lung Adenocarcinoma","KRAS G12V","Pancreatic Cancer","Colorectal Cancer",[35,36,37,38,39,40,41,42,43,31,44,45],"TCR-T","TCR-T cell therapy","PDAC","CRC","LUAD","Pancreatic cancer","Colorectal cancer","NSCLC","KRAS","HLA-A*11:01","Solid tumors","NOT_YET_RECRUITING","2026-10-08",{"date":49,"type":50},"2026-10-15","ACTUAL",{"date":52,"type":21},"2026-10",{"date":54,"type":21},"2033-03",{"name":56,"class":57},"Neowise Biotechnology","INDUSTRY",{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100613415","phase-1-tcr-engineered-t-cells-nw-101c-in-patients-with-solid-malignant-tumors-100613415","NCT07266298","TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors","A Phase I, Multicenter, Dose-escalation, Single-arm Study of PRAME Antigen-targeted TCR-T Cells(NW-101C) in the Treatment of Subjects With Advanced Solid Malignant Tumors.","Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumors and must have no standard treatment options available or unable to tolerate the currently available standard treatments\n* For patients with ovarian caner :Patients must have confirmed diagnosis of Platinum-resistant ovarian epithelial carcinoma(PROC)\n* HLA-A\\*02:01positive\n* Patient's tumor must express PRAME assessed by central lab,Retrospective testing will be required for patients that qualify.\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\nExclusion 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)",{"count":66,"type":21},24,[24],"This clinical trial is a prospective, dose-escalation, multicenter, single- arm, Phase 1 clinical trial to evaluate the safety, tolerability, PK and preliminary clinical activity of PRAME Antigen-targeted TCR-T Cells (NW-101C) infusion in patients with previously heavily treated, metastatic solid malignant tumors.",[70],"Solid Metastatic Tumor","RECRUITING","2025-12-04",{"date":74,"type":50},"2025-12-12",{"date":76,"type":21},"2025-12",{"date":78,"type":21},"2030-12",{"name":56,"class":57},1,""]