[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613415":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":45,"overallOfficials":30,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":30,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":30,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Neowise Biotechnology","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluate the Dose-limiting toxicities(DLTs) of NW-101C in patients with solid malignant tumors","Type, frequency and severity of adverse events assessed by CTCAE5.0","28 days following NW-101C infusion",{"measure":14,"description":11,"timeFrame":15},"Evaluate the Maximum Tolerated Dose (MTD) of NW-101C in patients with solid malignant tumors","Through the study completion, an average of 2 years",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"Evaluate the AUC of NW-101C in patients with solid malignant tumors","Area under the Plasma concentration versus time curve(AUC) assessed centrally","2 years following NW-101C infusion",{"measure":22,"description":23,"timeFrame":20},"Evaluate the Objective response rate (ORR) of NW-101C in patients with solid malignant tumors","Complete response (CR) and partial response (PR) assessed by investigators following RECIST1.1 criteria",{"measure":25,"description":26,"timeFrame":15},"Evaluate the Cmax of NW-101C in patients with solid malignant tumors","Maximum Concentration(Cmax) assessed centrally",{"measure":28,"description":29,"timeFrame":15},"Evaluate the Tmax of NW-101C in patients with solid malignant tumors","Time of Maximum Concentration assessed centrally",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NA","SEQUENTIAL","A classic 3+3 model will be used to dose escalation,4 doses will be used: 4×10\\^8±30%, 8×10\\^8±30%, 15×10\\^8±30% and 30×10\\^8±30% TCR-T cells\u002F patients","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","Using a classic 3+3 dose escalation design, this study will enroll \\~24 subjects to characterize the safety and preliminary anti-tumor activity of NW-101C.\n\nSCREENING: Patient eligibility will be determined by protocol inclusion\u002Fexclusion criteria including HLA (human leukocyte antigen) and a biopsy (or collection of archival tumor tissue) for biomarker screening. Leukapheresis for potential manufacturing of the NW-101C cellular product may be performed,if patients are HLA-A\\*02:01 positive and meet the eligibility criteria for leukapheresis.\n\nMANUFACTURING: NW-101C products will be made from the patients' white blood cells.\n\nTREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the NW-101C product infusion to improve the duration of time that NW-101C product stays in the body. The patient will be admitted to the hospital during the T-cell infusion until 28 days following NW-101C infusion. After the NW-101C product infusion, dose -limiting toxicities (DLT) will be assessed from the infusion of NW-101C until 28 days following the infusion of NW-101C.",[40],{"label":41,"type":42,"description":30,"interventionNames":43},"NW-101C dose 1-4","EXPERIMENTAL",[44],"Biological: NW-101C",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"BIOLOGICAL","NW-101C","4 dosage of NW-101C will be tested in this study using classic 3+3 dose escalation approach: 4×10\\^8±30%, 8×10\\^8±30%,15×10\\^8±30% and 30×10\\^8±30% TCR-T+ cells",[41],[52],{"name":53,"role":54,"phone":55,"phoneExt":30,"email":56},"Yuhui He","CONTACT","0512-67991566","yuhui.he@neowisebio.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":30,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Beijing Cancer hosptial","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":66,"coordinates":67},"Point",[68,69],116.39723,39.9075,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":74,"phoneExt":30,"email":75},"Lin Shen, Medical Doctor","010-88121122","doctorshenlin@sina.com",{"type":77,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100613415","phase-1-tcr-engineered-t-cells-nw-101c-in-patients-with-solid-malignant-tumors-100613415",false,"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)","ALL","18 Years","75 Years",{"count":89,"type":90},24,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","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.",[96],"Solid Metastatic Tumor","2025-12-04",{"date":99,"type":100},"2025-12-12","ACTUAL",{"date":102,"type":90},"2025-12",{"date":104,"type":90},"2030-12",{"name":5,"class":6},1]