[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413241":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":32,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of CD19 CAR T-cells","EXPERIMENTAL",null,[13],"Drug: CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CD19 CAR-T cells","Each subject receive CD19 CAR T-cells by intravenous infusion",[9],[21],"CD19 CAR-T cells injection",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"He Huang, PhD","CONTACT","86-13605714822","hehuangyu@126.com",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},"Yongxian Hu, PhD","86-15957162012","huyongxian2000@aliyun.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The First Affiliated Hospital，College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[54],{"name":55,"class":56},"Yake Biotechnology Ltd.","INDUSTRY","100413241","phase-2-cd19-car-t-therapy-for-patients-with-newly-diagnosed-high-risk-large-b-cell-lymphoma-100413241",false,"NCT04661020","CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma","Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Age no less than 18, no gender limit;\n2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and\u002For BCL6, (3) HGBL not otherwise specified;\n3. Confirmed CD19 and CD20 postive expressions in lymphoma cells\n4. ECOG score 0-2;\n5. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n8. Estimated survival time ≥ 3 months;\n9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n4. Active infection of hepatitis B virus or hepatitis C virus;\n5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;\n6. Insufficient amplification capacity in response to CD3\u002FCD28 co-stimulus signal (\\\u003C5 times) ;\n7. Other uncontrolled diseases that were not suitable for this trial;\n8. Patients with HIV infection;\n9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","ALL","18 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma",[74],"Large B-Cell Lymphoma (LBCL)",[76,77,78],"CD19","Large B-Cell Lymphoma","CAR-T","2026-04-01",{"date":81,"type":82},"2026-04-07","ACTUAL",{"date":84,"type":82},"2020-12-03",{"date":86,"type":68},"2026-12-20",{"name":5,"class":6},1]