[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506987":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":70,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":24,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"TCRCure Biopharma Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"dose escalation","EXPERIMENTAL","This study uses the \"3+3\" dose escalation method. The initial dose is Dose 1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment. If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose -1 infusion.\n\nInterventions:\n\nBiological: TCR-T cells Drug: IL-2 Drug: Fludarabine Drug: Cyclophosphamide Drug: Nab-Paclitaxel",[13,14,15,16,17],"Biological: TC-N201 cells","Drug: IL-2","Drug: Fludarabine","Drug: Cyclophosphamide","Drug: Nab-paclitaxel",[19,25,30,34,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","TC-N201 cells","T cells genetically engineered with a TCR targeting NY-ESO-1 (NY-ESO-1 TCR) that displays specific reactivity against HLA-A2+, NY-ESO-1+ target cells.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","IL-2","Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Fludarabine","Part of the non-myeloablative lymphocyte-depleting preparative regimen.",[9],{"type":26,"name":35,"description":32,"armGroupLabels":36,"otherNames":24},"Cyclophosphamide",[9],{"type":26,"name":38,"description":32,"armGroupLabels":39,"otherNames":24},"Nab-paclitaxel",[9],[41],{"name":42,"affiliation":43,"role":44},"ning Li, PhD","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":24,"email":49},"CONTACT","010-87788713","lining@cicams.ac.cn",[51],{"facility":5,"status":52,"city":53,"state":24,"zip":24,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Chongqing","China","CN",{"type":57,"coordinates":58},"Point",[59,60],106.55771,29.56026,{"lat":60,"lon":59},[63,66,69],{"name":64,"role":47,"phone":65,"phoneExt":24,"email":24},"xiaochun cheng","18883244981",{"name":67,"role":47,"phone":68,"phoneExt":24,"email":24},"miaomiao wang","18716369572",{"name":42,"role":44,"phone":24,"phoneExt":24,"email":24},{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[73],{"name":43,"class":74},"OTHER","100506987","phase-1-ny-eso-1-tcr-t-cells-for-ny-eso-1-positive-subjects-with-advanced-solid-tumors-100506987",false,"NCT05881525","NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors","A Phase I\u002FII Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.","Inclusion Criteria:\n\n* Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;\n* Age ≥ 18 years and ≤ 70 years;\n* Expected survival time \\> 3 months;\n* ECOG score 0-1;\n* Metastatic or recurrent solid tumors confirmed by histopathology;\n* Refractory to standard treatment evaluated by radiological assessment;\n* Be able provide fresh or preserved tissue specimen;\n* At least 1 measurable lesion (according to RECIST 1.1);\n* NY-ESO-1 expression positive: Immunohistochemical staining positive cells ≥25% and positive staining intensity is \"++\" or above;\n* HLA typing is HLA-A2 (excluding HLA-A\\*0203);\n* Hematology should at least meet the following criteria:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5× 109\u002FL (±20%)；\n  2. Platelet (PLT） ≥ 75× 109\u002FL (±20%）；\n  3. Hemoglobin (HGB) ≥ 90 g\u002FL (±20%).\n* Liver and kidney function are normal:\n\n  1. Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml\u002Fmin;\n  2. Serum Alanine aminotransferase (ALT) or\u002Fand Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal;\n  3. Total bilirubin (TBIL) ≤ 15 times of upper limit of normal.\n* Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN;\n* Echocardiogram results show: Left ventricular ejection fraction \\>45%;\n* Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug Note: Women of childbearing age who have undergone surgical sterilization or who have already experienced menopause are considered to have no possibility of pregnancy.\n* Before the TC-N201 injection was reconstituted, the toxic effects of standard treatment had already recovered, and the corresponding adverse events were judged by the researcher to not pose a safety risk;\n* Catheter insertion is feasible and No White Blood Cells collection contraindications.\n\nExclusion Criteria:\n\n* Under pregnancy or lactation, or positive based on blood pregnancy test;\n* Severe allergic to related ingredients in the clinical trial;\n* Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time;\n* History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured;\n* Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment;\n* Subjects with any active autoimmune disease, a history of autoimmune disease, or a history or syndrome requiring treatment with systemic steroids or immunosuppressive drugs;\n* Immunodeficiency including HIV positive, harvested or natural immunodeficiency;\n* Subjects with ≥ grade 3 thromboembolic events within 2 years or under thrombolysis treatment;\n* Subjects with hereditary or acquired hemorrhagic disease;\n* Have clinical cardiovascular disease or symptoms;\n* Subjects with active infection: active infection requiring systemic anti-infective treatment (except topical antibiotics), fever caused by cancer could be enrolled according to the investigator's judgment;\n* Subjects with active pulmonary tuberculosis infection detected by medical history or Computed Tomography (CT), or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;\n* Subjects with positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody;\n* Treponema pallidum antibody positive;\n* Subjects received major surgery or under severe injury within 4 weeks before TC-N201 cell infusion;\n* Subjects who received live vaccine or attenuated live vaccine 28 days before leukapheresis;\n* Subjects who have drug addiction history, or alcoholism, drug users;\n* Subjects who received cell therapy before enrollment，such as TCR-T，CAR-T and TIL;\n* Subjects who have previously received treatment targeting NY-ESO-1;\n* Subjects not suitable for the clinical trial according to investigators.","ALL","18 Years","70 Years",{"count":86,"type":87},18,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.",[93],"Advanced Solid Tumors","2025-07-11",{"date":96,"type":97},"2025-07-16","ACTUAL",{"date":99,"type":97},"2023-06-01",{"date":101,"type":87},"2026-12",{"name":5,"class":6},1]