[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542749":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":58,"id":62,"slug":30,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":30,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":30,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of CD19-BAFF 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: CD19-BAFF Targeted CAR T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19-BAFF Targeted CAR T-cells","Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion",[9],[21],"CD19-BAFF Targeted CAR T-cells injection",[23],{"name":24,"affiliation":5,"role":25},"He Huang, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","86-13605714822",null,"hehuangyu@126.com",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Yongxian Hu, MD","86-15957162012","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","310000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},[52,53],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":54,"phoneExt":30,"email":35},"+8615957162012",{"type":25,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"He Huang","Clinical Professor",[59],{"name":60,"class":61},"Yake Biotechnology Ltd.","INDUSTRY","100542749",false,"NCT06346912","CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed \u002F Refractory B-cell ALL and B-cell NHL","A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell ALL and B-cell NHL","Inclusion Criteria:\n\n* 1\\. Gender unlimited，18\\\u003C Age;\n* 2\\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma\n* 3\\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n  1. CR not achieved after standardized chemotherapy;\n  2. CR achieved following the first induction, but CR duration is less than 12 months;\n  3. Ineffectively after first or multiple remedial treatments;\n  4. 2 or more relapses;\n* 4\\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (by morphology), and\u002For \\>1% (by flow cytometry);\n* 5\\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* 6\\. Relapsed or refractory B-NHL (meeting one of the following conditions):\n\n  1. No response or relapse after second-line or above chemotherapy regimens;\n  2. Primary drug resistance;\n  3. Relapse after auto-HSCT;\n* 7\\. At least one assessable tumor lesion per Lugano 2014 criteria;\n* 8\\. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n* 9\\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* 10\\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* 11\\. Estimated survival time ≥ 3 months;\n* 12\\. ECOG performance status 0 to 2;\n* 13\\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Pregnant\u002Flactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion\n* 4\\. Patients with HIV infection;\n* 5\\. Active infection of hepatitis B virus or hepatitis C virus;\n* 6\\. The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* 7\\. Other uncontrolled diseases that were not suitable for this trial;\n* 8\\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;\n* 9\\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","ALL","18 Years",{"count":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"EARLY_PHASE1","Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory\u002Frelapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.",[78,79],"Acute Lymphoblastic Leukemia,B-Cell","Non-hodgkin Lymphoma,B Cell",[81],"CD19-BAFF CAR-T","2024-05-13",{"date":84,"type":85},"2024-05-14","ACTUAL",{"date":87,"type":72},"2024-05-30",{"date":89,"type":72},"2027-05-30",{"name":5,"class":6},1]