[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354192":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":39,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":39,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":48,"whyStopped":39,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Guangzhou FineImmune Biotechnology Co., LTD.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TCR-T cell infusion","EXPERIMENTAL","Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy",[13,14],"Drug: tumor-specific TCR-T cells","Drug: Interleukin-2",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","tumor-specific TCR-T cells","On day 0 and day 14, 0.5-5x10\\^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.",[9],[22,23],"TCR-T cells","FIT-001",{"type":17,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Interleukin-2","Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .",[9],[29],"IL-2",[31],{"name":32,"affiliation":5,"role":33},"Penghui Zhou","STUDY_DIRECTOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Xuzhi Pan","CONTACT","86-20-87343135",null,"panxzh@sysucc.org.cn",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Haiping Liu","020-31605836","liuhp11@fineimmu.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Gaungdong","510700","China","CN",{"type":55,"coordinates":56},"Point",[57,58],113.25,23.11667,{"lat":58,"lon":57},[61,62],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":63,"role":37,"phone":39,"phoneExt":39,"email":39},"Xiaoshi Zhang, professor",{"type":65,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[67],{"name":68,"class":69},"Sun Yat-Sen University Cancer Center","OTHER","100354192","phase-1-individualized-tumor-specific-tcr--t-cells-in-the-treatment-of-advanced-solid-tumors-100354192",false,"NCT03891706","Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors","An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Aged between 18 and 70 years old, regardless of gender;\n2. Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;\n3. Be after standard treatment or who lack effective treatment programs;\n4. Patients and their families were willing to participate in the clinical trial and signed the informed consent;\n5. Physical status: ECOG score 0-1;\n6. Expected survival time \\> 3 months;\n7. HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte \\>0.8×10\\^9\u002FL, hemoglobin \\>100g\u002FL, and the pregnancy test of female patients with fertility potential was negative.\n8. Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT\u002FAST \\\u003C 2.5 times;Serum creatinine 1.6mg\u002Fdl;Total bilirubin 1.5mg\u002Fdl, subject's total bilirubin \\\u003C 3mg\u002Fdl except for Gilberts Syndrome;\n9. At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.\n10. During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;\n11. The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;\n12. Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;\n13. T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;\n14. The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.\n\nExclusion Criteria:\n\n1. Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);\n2. Experiencing moderate to severe infection or possible opportunistic infection;\n3. Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);\n4. Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;\n5. Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;\n6. Be allergic to any drug used in this study;\n7. Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;\n8. Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.","ALL","18 Years","70 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .\n\nThe secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .",[88],"Solid Tumor",[90],"TCR-T","2024-09-13",{"date":93,"type":94},"2024-09-19","ACTUAL",{"date":96,"type":94},"2019-01-08",{"date":98,"type":82},"2025-12-31",{"name":5,"class":6},1]