[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354192":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":41,"overallOfficials":56,"centralContacts":60,"locations":70,"responsibleParty":89,"collaborators":91,"id":95,"slug":25,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":25,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":25,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Guangzhou FineImmune Biotechnology Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.03","Keep records the adverse events experienced by subjects in 30 days after the last infusion.","At least 45 days",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Disease Control Rate(DCR)","DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST","one year",{"measure":19,"description":20,"timeFrame":21},"overall survival(OS)","The time from the first injection of Investigational Product until death","two year",{"measure":23,"description":24,"timeFrame":21},"progression-free survival(PFS)","PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"TCR-T cell infusion","EXPERIMENTAL","Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy",[39,40],"Drug: tumor-specific TCR-T cells","Drug: Interleukin-2",[42,50],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"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.",[35],[48,49],"TCR-T cells","FIT-001",{"type":43,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Interleukin-2","Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .",[35],[55],"IL-2",[57],{"name":58,"affiliation":5,"role":59},"Penghui Zhou","STUDY_DIRECTOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},"Xuzhi Pan","CONTACT","86-20-87343135","panxzh@sysucc.org.cn",{"name":67,"role":63,"phone":68,"phoneExt":25,"email":69},"Haiping Liu","020-31605836","liuhp11@fineimmu.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Gaungdong","510700","China","CN",{"type":80,"coordinates":81},"Point",[82,83],113.25,23.11667,{"lat":83,"lon":82},[86,87],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},{"name":88,"role":63,"phone":25,"phoneExt":25,"email":25},"Xiaoshi Zhang, professor",{"type":90,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[92],{"name":93,"class":94},"Sun Yat-Sen University Cancer Center","OTHER","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":105,"type":106},30,"ESTIMATED","INTERVENTIONAL",[109],"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 .",[112],"Solid Tumor",[114],"TCR-T","2024-09-13",{"date":117,"type":118},"2024-09-19","ACTUAL",{"date":120,"type":118},"2019-01-08",{"date":122,"type":106},"2025-12-31",{"name":5,"class":6},1]