[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":31,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":31,"maxAge":31,"enrollmentInfo":69,"targetDuration":31,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of CD5+ T-ALL Targeted CAR T-cells","EXPERIMENTAL","Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.",[13],"Biological: CD5 CAR T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD5 CAR T-cells","Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion",[9],[21],"CD5+ T-ALL Targeted CAR T-cells injection",[23],{"name":24,"affiliation":25,"role":26},"He Huang, MD","First Affiliated Hospital of Zhejiang University","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","057187233772",null,"hehuangyu@126.com",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Yongxian Hu, MD","huyongxian2000@aliyun.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},[52,53],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},{"type":26,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"He Huang","Clinical Professor",[58],{"name":59,"class":60},"Yake Biotechnology Ltd.","INDUSTRY","100564759","early-phase-1-targeting-cd5-car-t-cells-in-the-treatment-of-rr-cd5-t-all-100564759",false,"NCT06633354","Targeting CD5 CAR-T Cells in the Treatment of r\u002Fr CD5+ T-ALL","A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r\u002Fr CD5+ T-ALL","Inclusion Criteria:\n\n* 1\\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;\n* 2\\. Consistent with r\u002Fr CD5+T-ALL diagnosis, including any of the following conditions:\n\n  1. No CR after standard chemotherapy;\n  2. The first induction reaches CR, but CR ≤ 12 months;\n  3. Patients with r\u002Fr CD5+T-ALL have not responded to the first or multiple remedial treatments;\n\n  c.Multiple recurrences.\n* 3\\. CD5 expression rate was \\>90%;\n* 4\\. Number of blasts in the bone marrow (protolychic + larvae) \\>5% (morphology) and\u002For \\>1% (flow cytometry);\n* 5\\. Total bilirubin ≤51 (mol\u002FL), Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol\u002FL);\n* 6\\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;\n* 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);\n* 8.Estimated life expectancy of minimum of 12 weeks;\n* 9.ECOG 0-2;\n* 10.Pregnant\u002Flactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;\n* 11\\. Those who voluntarily participated in this trial and provided informed consent;\n\nExclusion Criteria:\n\n* 1.Patients with the history of epilepsy or other CNS disease;\n* 2\\. Patients with prolonged QT interval time or severe heart disease;\n* 3\\. Active infection of hepatitis B virus, C virus or hepatitis E virus;\n* 4\\. Active infection with no cure;\n* 5\\. Before using any gene therapy products;\n* 6\\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:\n\n  1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \\\u003C 10 mg\u002Fd or an equivalent dose of the drug);\n  2. received within 72 hours of small molecule targeted therapy;\n  3. 2 weeks received systemic chemotherapy except (pretreatment);\n  4. four weeks received radiotherapy;\n* 7\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 8\\. Any unsuitable to participate in this trial judged by the investigator;\n* 9\\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.","ALL",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r\u002Fr CD5+ T-ALL",[77],"T-Acute Lymphoblastic Leukemia",[79],"CD5 CAR-T","2024-10-08",{"date":82,"type":83},"2024-10-09","ACTUAL",{"date":85,"type":71},"2024-10-20",{"date":87,"type":71},"2027-10-20",{"name":5,"class":6},1]