[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486946":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"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":34,"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","CD7 CAR-T treatment group",[13],"Biological: CD7 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD7 CAR-T cells","patient was subjected to 0.5-2×10\\^6 cells\u002Fkg of CD7 CAR- T",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Li Yu, Dr","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Yu Li, Dr","CONTACT","+8675521839178","liyu@vip.163.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Li Yu","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],114.0683,22.54554,{"lat":44,"lon":43},[47],{"name":33,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"YuLi","Professor","100486946","cd7-car-t-cells-in-t-cell-lymphomaleukemia-100486946",false,"NCT05620680","CD7 CAR-T Cells in T-cell Lymphoma\u002FLeukemia","Study of CD7 CAR-T Cells in Adult Refractory and Recurrent T-cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;\n2. The subject voluntarily participates in the research and signs the \"Informed Consent\" by himself or his legal guardian;\n3. According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)\u002Facute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma;\n4. Meet the diagnostic criteria for relapsed\u002Frefractory T-cell lymphoma, including any of the following:\n\n1\\) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion \\>5%), or extramedullary diseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOG score of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expected survival time of more than 3 months.\n\nExclusion Criteria:\n\n1. Those who have a history of allergy to any of the ingredients in cell products;\n2. Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg\u002Fdl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg\u002Fdl; Platelet count≦ 10×109\u002FL;\n3. Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) \\\u003C 50%;\n4. Abnormal lung function, blood oxygen saturation under indoor air \\\u003C 92%;\n5. Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;\n6. Grade 3 hypertension with poor control of blood pressure with medication;\n7. Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled);\n8. Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;\n9. Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and\u002For ongoing head and\u002For spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment;\n10. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy;\n11. presence of uncontrolled, active infection;\n12. Have previously used any CAR-T cell product or other genetically modified T cell therapy;\n13. Live vaccination within 4 weeks prior to enrollment;\n14. HIV, HBV, HCV and TPPA\u002FRPR infections, and HBV carriers;\n15. Subject has a history of alcoholism, drug addiction or mental illness;\n16. The subject has participated in any other clinical research within 3 months before joining this clinical study;\n17. Female subjects have any of the following conditions: a) are pregnant\u002Flactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception;\n18. There are other circumstances in which the investigator believes that the subject is not suitable for this study.","ALL","18 Years","75 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"NA","T-cell lymphoma\u002Fleukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.\n\nIn this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma\u002Fleukemia.",[69],"T Lymphoblastic Leukemia\u002FLymphoma","2022-11-11",{"date":72,"type":73},"2022-11-17","ACTUAL",{"date":75,"type":73},"2022-10-01",{"date":77,"type":63},"2028-10-31",{"name":5,"class":6},1]