[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486946":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":18,"id":69,"slug":18,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":18,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":52,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"TEAEs","Adverse events during treatment","From date of initial treatment to the 30 days after treatment",[14],{"measure":15,"description":16,"timeFrame":17},"overall response rate","the proportion of complete and partial response patients","baseline and 8 weeks, up to 1 year",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","T-cell lymphoma accounts for 10%\\~15% of non-Hodgkin lymphoma in China. According to the World Health Organization (WHO), T-cell lymphoma was divided into the following subtypes: T-cell, NK cell lymphoma\u002Fleukemia. There were two major categories: anterior T-cell tumors and posterior thymic T-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral T-cell lymphomas.\n\nGenerally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. Collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients.\n\nCD7 is a transmembrane glycoprotein that plays an important role in T-cell and T-cell\u002FB-cell interactions during early lymphoid development. The expression of CD7 persist from stem to mature T cells. 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 testify the safy and efficacy of CD7 CAR-T cells in T-cell lymphoma\u002Fleukemia.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"Treatment group","EXPERIMENTAL","CD7 CAR-T treatment group",[32],"Biological: CD7 CAR-T cells",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":18},"BIOLOGICAL","CD7 CAR-T cells","patient was subjected to 0.5-2×10\\^6 cells\u002Fkg of CD7 CAR- T",[28],[40],{"name":41,"affiliation":5,"role":42},"Li Yu, Dr","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":18,"email":48},"Yu Li, Dr","CONTACT","+8675521839178","liyu@vip.163.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Li Yu","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],114.0683,22.54554,{"lat":62,"lon":61},[65],{"name":51,"role":46,"phone":47,"phoneExt":18,"email":48},{"type":42,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"YuLi","Professor","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":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[20],"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.",[85],"T Lymphoblastic Leukemia\u002FLymphoma","2022-11-11",{"date":88,"type":89},"2022-11-17","ACTUAL",{"date":91,"type":89},"2022-10-01",{"date":93,"type":80},"2028-10-31",{"name":5,"class":6},1]