[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TCRCure Biopharma Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100630432","early-phase-1-functionally-enhanced-alpp-targeted-engineered-t-cells-in-advanced-solid-tumors-100630432",false,"NCT07487597","Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors","A Single-Arm, Single-Center, Open-Label Pilot Study of Functionally Enhanced ALPP-Targeted Engineered T Cells for Patients With ALPP-Positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-70 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. ALPP-positive tumor confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B\u002FC, syphilis).\n8. Pregnant or breastfeeding women.\n9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding.\n10. Severe systemic or psychiatric illness.\n11. Prior cell or gene therapy.\n12. Severe drug hypersensitivity history.\n13. Investigator-assessed unsuitability for trial participation.","ALL","18 Years","70 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.",[27],"Solid Tumor",[29,30,31],"Advanced Solid Tumor","ALPP","CAR-T","RECRUITING","2026-03-17",{"date":35,"type":36},"2026-03-23","ACTUAL",{"date":38,"type":36},"2026-02-28",{"date":40,"type":21},"2029-02-28",{"name":42,"class":43},"TCRCure Biopharma Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100611878","early-phase-1-tc-d101-cell-therapy-for-patients-with-dll3-positive-sclc-100611878","NCT07246304","TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC","A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed\u002FRefractory Primary Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-75 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. DLL3-positive r\u002Fr SCLC confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B\u002FC, syphilis).\n8. Pregnant or breastfeeding women.\n9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.\n\n11\\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.","75 Years",{"count":20,"type":21},[24],"This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed\u002FRefractory primary small cell lung cancer(r\u002Fr SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.",[57,58],"Small Cell Lung Cancer ( SCLC )","CAR-T Cell Therapy",[57,58,60],"DLL3","2025-11-17",{"date":63,"type":36},"2025-11-24",{"date":65,"type":21},"2025-11-30",{"date":67,"type":21},"2028-11-30",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":44},"100506987","phase-1-ny-eso-1-tcr-t-cells-for-ny-eso-1-positive-subjects-with-advanced-solid-tumors-100506987","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.",{"count":77,"type":21},18,[79],"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.",[82],"Advanced Solid Tumors","2025-07-11",{"date":85,"type":36},"2025-07-16",{"date":87,"type":36},"2023-06-01",{"date":89,"type":21},"2026-12",{"name":42,"class":43},""]