[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403359":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":50,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":22,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":36,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of Humanized CD19 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],"Drug: Humanized CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Humanized CD19 CAR-T cells","Each subject receive humanized CD19 CAR T-cells by intravenous infusion",[9],[21],"Humanized CD19 CAR-T cells injection",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"He Huang, PhD","CONTACT","86-13605714822","hehuangyu@126.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Yongxian Hu, PhD","86-15957162012","huyongxian2000@aliyun.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital，College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.16142,30.29365,{"lat":46,"lon":45},[49],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor",[55],{"name":56,"class":57},"Yake Biotechnology Ltd.","INDUSTRY","100403359","early-phase-1-a-study-of-humanized-cd19-car-t-cells-therapy-for-patients-with-relapsed-andor-refractory-b-cell-all-and-b-cell-nhl-100403359",false,"NCT04532268","A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell ALL and B-cell NHL","Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Inclusion criteria only for B-ALL:\n\n  1. Male or female aged 3-70 years;\n  2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\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* Inclusion criteria only for B-NHL:\n\n  1. Male or female aged 18-75 years;\n  2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL\u002FSLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);\n  3. 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  4. At least one assessable tumor lesion per Lugano 2014 criteria;\n* Common inclusion criteria for B-ALL and B-NHL:\n\n  1. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n  2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n  3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n  4. Estimated survival time ≥ 3 months;\n  5. ECOG performance status 0 to 2;\n  6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. 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. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine \\>2.5mg\u002Fdl, or ALT \u002F AST\\>3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","ALL","3 Years","75 Years",{"count":69,"type":70},72,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.",[76,77],"Acute Lymphoblastic Leukemia","Non-hodgkin Lymphoma,B Cell",[76,79,80],"Non-Hodgkin's Lymphoma","CAR T-cell therapy","2020-08-25",{"date":83,"type":84},"2020-08-31","ACTUAL",{"date":86,"type":70},"2020-08-23",{"date":88,"type":70},"2026-08-23",{"name":5,"class":6},1]