[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630432":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":44,"overallOfficials":52,"centralContacts":57,"locations":63,"responsibleParty":78,"collaborators":29,"id":80,"slug":29,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":29,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"TCRCure Biopharma Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety of Enhanced ALPP CAR-T cells","The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.","Up to 24 months",{"measure":10,"description":14,"timeFrame":15},"Incidence of DLT","Up to 1 month",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Efficacy of Enhanced ALPP CAR-T cells","Optimal objective response rate (ORR)",{"measure":21,"description":22,"timeFrame":12},"To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion","To detect ALPP CAR copies in peripheral blood, then calculated Cmax.",{"measure":24,"description":25,"timeFrame":12},"To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion","To detect ALPP CAR-T cell number in tumor tissues after infusion",{"measure":27,"description":28,"timeFrame":12},"To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion","To detect ALPP CAR copies in peripheral blood, then calculated AUC.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of Enhanced ALPP CAR-T in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Enhanced ALPP CAR-T","EXPERIMENTAL","Following lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion.",[43],"Biological: Enhanced ALPP CAR-T treatment",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"BIOLOGICAL","Enhanced ALPP CAR-T treatment","Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.",[39],[51],"Fludarabine Cyclophosphamide",[53],{"name":54,"affiliation":55,"role":56},"Tangfeng Lv, MD","The Jinling Hospital","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":29,"email":62},"Tangfeng LV, MD","CONTACT","02580863234","njzyjg80863256@163.com",[64],{"facility":55,"status":65,"city":66,"state":67,"zip":29,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Nanjing","Jiangsu","China","CN",{"type":71,"coordinates":72},"Point",[73,74],118.77778,32.06167,{"lat":74,"lon":73},[77],{"name":54,"role":60,"phone":61,"phoneExt":29,"email":62},{"type":79,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":90,"type":91},24,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97],"Solid Tumor",[99,100,101],"Advanced Solid Tumor","ALPP","CAR-T","2026-03-17",{"date":104,"type":105},"2026-03-23","ACTUAL",{"date":107,"type":105},"2026-02-28",{"date":109,"type":91},"2029-02-28",{"name":5,"class":6},1]