[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486947":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","TCR-T treatment group",[13],"Biological: NY-ESO-1 TCR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","NY-ESO-1 TCR-T","NY-ESO-1 TCR-T treatment",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Li Yu, Dr","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+8675521839178","liyu@vip.163.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Li Yu","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],114.0683,22.54554,{"lat":43,"lon":42},[46],{"name":32,"role":27,"phone":28,"phoneExt":20,"email":47},"liyu_gcp@163.com",{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"YuLi","Professor","100486947","study-of-ny-eso-1-tcr-t-in-advanced-soft-tissue-sarcoma-100486947",false,"NCT05620693","Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Study NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Aged 18-70 (≥ 18, ≤ 70), regardless of gender;\n2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;\n3. Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;\n4. According to RECIST 1.1 standard, there are clear assessable lesions;\n5. The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02\u002F01;\n6. Within 2 weeks before cell therapy, no antibody drugs were used;\n7. ECOG score is 0-2;\n8. The subject has no contraindication for peripheral blood collection;\n9. The expected survival period is more than 3 months.\n\nExclusion Criteria:\n\n1. People who have a history of allergy to any component in cell products;\n2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109\u002FL, absolute value of neutrophil ANC ≤ 0.5 × 109\u002FL, absolute value of lymphocyte ALC ≤ 0.5 × 109\u002FL , PLT≦25 × 109\u002FL ；\n3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg\u002Fdl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg\u002Fdl;\n4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\\\u003C50% by echocardiography;\n5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;\n7. Grade 3 hypertension and poor blood pressure control after drug treatment;\n8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;\n9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;\n10. There is uncontrolled active infection;\n11. Have used any cell therapy products in recent 3 months;\n12. Live vaccine inoculation within 4 weeks before enrollment;\n13. HIV, HBV, HCV and TPPA\u002FRPR positive persons, and HBV carriers;\n14. Subjects have a history of alcohol abuse, drug abuse or mental illness;\n15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;\n16. Female subjects have any of the following conditions: a) are in pregnancy\u002Flactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;\n17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.","ALL","18 Years","70 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"NA","Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no standard second-line treatment plan for patients who have failed first-line treatment. NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an ideal therapeutic target.\n\nInvestigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced soft tissue sarcoma.",[69],"Advanced Soft-tissue Sarcoma","2022-11-17",{"date":72,"type":73},"2022-11-22","ACTUAL",{"date":75,"type":73},"2022-11-11",{"date":77,"type":63},"2028-12-01",{"name":5,"class":6},1]