[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403354":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":28,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":64,"conditions":76,"keywords":79,"overallStatus":42,"whyStopped":28,"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 CAR T-cells","EXPERIMENTAL","Dose escalation follows the standard 3+3 doseescalation design. A total of 3 dose levels are set for subjects.",[13,14],"Drug: CAR-T cells","Procedure: Ommaya Reservoir",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","CAR-T cells","Each subject receive CAR T-cells by intravenous infusion",[9],[22],"CAR-T cells injection",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Ommaya Reservoir","Surgical catheter placement into the fourth ventricle of the brain",[9],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"He Huang, PhD","CONTACT","86-13605714822","hehuangyu@126.com",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Yongxian Hu, PhD","86-15957162012","huyongxian2000@aliyun.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital，College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.16142,30.29365,{"lat":52,"lon":51},[55],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","He Huang","Clinical Professor","100403354","early-phase-1-a-study-of-car-t-cells-therapy-for-patients-with-relapsed-andor-refractory-central-nervous-system-hematological-malignancies-100403354",false,"NCT04532203","A Study of CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Central Nervous System Hematological Malignancies","Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia or 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 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 followingconditions):\n\n     1. CR not achieved after standardized chemotherapy;\n     2. CR achieved following the first induction, but CR duration isless 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 flowcytometry);\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 WHOClassification Criteria for Lymphoma (2016);\n  3. Relapsed or refractory B-NHL (meeting one of the followingconditions):\n\n     1. No response or relapse after second-line or abovechemotherapy 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. Highly suspected or confirmed central nervous system involvement of hematological malignancies;\n  2. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol\u002FL;\n  3. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n  4. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n  5. Estimated survival time ≥ 3 months;\n  6. ECOG performance status 0 to 2;\n  7. 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 urinarytractinfectionand 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,orbilirubin\\>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 ofpatients or interfere with the results of study.","ALL","3 Years","75 Years",{"count":71,"type":72},72,"ESTIMATED","INTERVENTIONAL",[75],"EARLY_PHASE1",[77,78],"Acute Lymphoblastic Leukemia","Non-Hodgkin's Lymphoma",[77,78,80],"CAR T-cell therapy","2020-10-22",{"date":83,"type":84},"2020-10-26","ACTUAL",{"date":86,"type":72},"2020-11-01",{"date":88,"type":72},"2026-11-01",{"name":5,"class":6},1]