[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532941":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":237,"collaborators":43,"id":239,"slug":240,"hasResults":241,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":43,"eligibilityCriteria":245,"healthyVolunteers":241,"sex":246,"minAge":247,"maxAge":43,"enrollmentInfo":248,"targetDuration":43,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":43,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Hangzhou GluBio Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation of GLB-002 in Participants with R\u002FR NHL-Phase 1a","EXPERIMENTAL","Part 1a (Dose Escalation) of the study will enroll R\u002FR NHL participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-002 administered orally, and determine the maximum tolerated dose (MTD) and\u002For recommended expansion doses (RED) in R\u002FR NHL patients who are eligible for dose limiting toxicity (DLT) evaluation.",[13],"Drug: GLB-002",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion of GLB-002 in Participants with R\u002FR FL (Grade 1, 2, 3a)-Phase 1b Cohort 1","Part 1b (Dose Expansion) Cohort 1 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R\u002FR Follicular Lymphoma (Grade 1、2、3a).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Expansion of GLB-002 in Participants with R\u002FR DLBCL and FL (Grade 3b)-Phase 1b Cohort 2","Confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R\u002FR Diffuse Large B-cell Lymphoma and R\u002FR Follicular Lymphoma (Grade 3b).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Expansion of GLB-002 in Participants with other R\u002FR NHL-Phase 1b Cohort 3","Part 1b (Dose Expansion) Cohort 3 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for other R\u002FR NHL, including, but not limited to Mantle-cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Small Lymphocytic Lymphoma (SLL) \u002FChronic Lymphocytic Leukemia (CLL) and Peripheral T-cell Lymphoma (PTCL).",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","GLB-002","Administered orally according to the assigned treatment schedule.",[9,19,15,23],[33],"GLB-A062-B",[35],{"name":36,"affiliation":5,"role":37},"Gang Lu, Ph.D.","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Jing Liu, MD","CONTACT","86-18616699599",null,"Jing.Liu@glubiotx.com",[46,65,75,89,104,122,136,150,165,179,194,207,222],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":43,"email":64},"Yuqing Song, MD","86-010-88121122","songyuqin622@163.com",{"facility":66,"status":48,"city":49,"state":50,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Peking University Third Hospital","100191",{"type":55,"coordinates":69},[57,58],{"lat":58,"lon":57},[72],{"name":73,"role":41,"phone":74,"phoneExt":43,"email":43},"Hongmei Jing, MD","86-010-82266699",{"facility":76,"status":48,"city":77,"state":78,"zip":79,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"The First Affiliated Hospital of Xiamen University","Xiamen","Fujian","361003",{"type":55,"coordinates":81},[82,83],118.08187,24.47979,{"lat":83,"lon":82},[86],{"name":87,"role":41,"phone":88,"phoneExt":43,"email":43},"Bing Xu, MD","86-0592-2132222",{"facility":90,"status":48,"city":91,"state":92,"zip":93,"country":52,"countryCode":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Sun Yat-Sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":55,"coordinates":95},[96,97],113.25,23.11667,{"lat":97,"lon":96},[100],{"name":101,"role":41,"phone":102,"phoneExt":43,"email":103},"Zhiming Li, MD","86-020-87343088","lizhm@sysucc.org.cn",{"facility":105,"status":48,"city":106,"state":107,"zip":108,"country":52,"countryCode":53,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Henan Cancer Hospital","Zhengzhou","Henan","450003",{"type":55,"coordinates":110},[111,112],113.64861,34.75778,{"lat":112,"lon":111},[115,119],{"name":116,"role":41,"phone":117,"phoneExt":43,"email":118},"Keshu Zhou, MD","86-0371-65587320","drzhouks77@163.com",{"name":120,"role":121,"phone":43,"phoneExt":43,"email":43},"Quande Lin, MD","SUB_INVESTIGATOR",{"facility":123,"status":48,"city":124,"state":125,"zip":126,"country":52,"countryCode":53,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430023",{"type":55,"coordinates":128},[129,130],114.26667,30.58333,{"lat":130,"lon":129},[133],{"name":134,"role":41,"phone":135,"phoneExt":43,"email":43},"Guohui Cui, MD","86-027-85726114",{"facility":137,"status":48,"city":138,"state":139,"zip":140,"country":52,"countryCode":53,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hunan Cancer Hospital","Changsha","Hunan","410000",{"type":55,"coordinates":142},[143,144],112.97087,28.19874,{"lat":144,"lon":143},[147],{"name":148,"role":41,"phone":149,"phoneExt":43,"email":43},"Yajun Li, MD","86-0731-88651900",{"facility":151,"status":48,"city":152,"state":153,"zip":154,"country":52,"countryCode":53,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Jiangxi Cancer Hospital","Nanchang","Jiangxi","330029",{"type":55,"coordinates":156},[157,158],115.85306,28.68396,{"lat":158,"lon":157},[161],{"name":162,"role":41,"phone":163,"phoneExt":43,"email":164},"Yuerong Shuang, MD","86-0791-88315120","shuangyr63@163.com",{"facility":166,"status":48,"city":167,"state":168,"zip":169,"country":52,"countryCode":53,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Shengjing Hospital of China Medical University","Shenyang","Liaoning","110004",{"type":55,"coordinates":171},[172,173],123.43278,41.79222,{"lat":173,"lon":172},[176],{"name":177,"role":41,"phone":178,"phoneExt":43,"email":43},"Wei Yang, MD","86-024-23896615",{"facility":180,"status":48,"city":181,"state":182,"zip":183,"country":52,"countryCode":53,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":55,"coordinates":185},[186,187],121.45806,31.22222,{"lat":187,"lon":186},[190],{"name":191,"role":41,"phone":192,"phoneExt":43,"email":193},"Jian Zhang, MD","86-021-64175590","syner2000@163.com",{"facility":195,"status":48,"city":196,"state":197,"zip":198,"country":52,"countryCode":53,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Shanxi Cancer hospital","Taiyuan","Shanxi","030000",{"type":55,"coordinates":200},[201,202],112.56028,37.86944,{"lat":202,"lon":201},[205],{"name":43,"role":41,"phone":206,"phoneExt":43,"email":43},"86-0351-4881611",{"facility":208,"status":48,"city":209,"state":210,"zip":211,"country":52,"countryCode":53,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Tianjing Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300020",{"type":55,"coordinates":213},[214,215],117.17667,39.14222,{"lat":215,"lon":214},[218],{"name":219,"role":41,"phone":220,"phoneExt":43,"email":221},"Lihua Qiu, MD","86-022-23109106","JZXQLH@163.com",{"facility":223,"status":48,"city":224,"state":225,"zip":226,"country":52,"countryCode":53,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"The First Affilicated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":55,"coordinates":228},[229,230],120.16142,30.29365,{"lat":230,"lon":229},[233],{"name":234,"role":41,"phone":235,"phoneExt":43,"email":236},"Hongyan Tong, MD","86-0571-87236114","tonghongyan@zju.edu.cn",{"type":238,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100532941","phase-1-a-study-of-glb-002-in-patients-with-relapsed-or-refractory-non-hodgkin-lymphomas-100532941",false,"NCT06219356","A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas (R\u002FR NHL)","Inclusion Criteria:\n\n* Participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments\u002Fprocedures being performed.\n* Participants is ≥18 years of age at the time of signing the ICF.\n* Participants with histopathologically or immunohistochemically confirmed NHL according to 2016 World Health Organization (WHO) haematolymphoid tumors criteria classification (CLL\u002FSLL diagnosis according to 2018 IWCLL) who have failed standard of care therapy or lack an effective treatment regimen.\n* Participants in Phase Ib screening period with measurable lesion, but no measurable nodal lesion limit for participants in Phase Ia.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.\n* Life expectancy \\> 3 months.\n* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.\n* Participants are willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Receipt of anticancer medications\u002Ftherapies such as chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal agent ≤ 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002; or chimeric antigen receptor T cell therapy (CAR-T) within 3 months prior to the first dose of GLB-002.\n* Currently enrolled in any other investigational drug study or participation within the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002 (exception of participants who participated in only one investigational drug study with overall survival follow-up).\n* Participants with unresolved clinically significant toxicities of \\> Grade 1 AE or not be recovered to baseline value from prior anticancer therapies with exception of alopecia or hyperpigmentation of the skin.\n* Participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.\n* Participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy, or participants requiring treatment with systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within the last 7 days prior to the first dose of GLB-002 or during the study period.\n* Receipt of Autologous Stem Cell Transplantation (ASCT) within the last 3 months, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-002.\n* Participants with known active leukemic involvement in central nervous system (CNS).\n* Participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).\n* History of, or current active cancer other malignancy for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc\n* QT interval interval \\>470 milliseconds (ms) using electrocardiographic (ECG) at Screening.\n* Participants has impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.\n* Participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).\n* Participants with known human immunodeficiency virus (HIV) infection.\n* Participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases\n* Participants with a condition that may affects the absorption, distribution, metabolism and excretion of GLB-002.\n* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme (CYP)3A4\u002F5 and\u002For P-glycoprotein (P-gp) within 7 days or 5 half-lives prior to the first dose of GLB-002, whichever is shorter.\n* Participants who have undergone major surgery within 28 days prior to the first dose of the GLB-002.\n* Pregnant or lactating women.\n* Participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF.\n* Participants,in the opinion of the Investigator, who are unsuitable to participate in the study.","ALL","18 Years",{"count":249,"type":250},110,"ESTIMATED","INTERVENTIONAL",[253],"PHASE1","Study GLB-002-01 is a first-in-human (FIH), phase 1, open-label, dose escalation and expansion clinical study, the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory Non-Hodgkin lymphomas (R\u002FR NHL).",[256],"Non-Hodgkin Lymphoma","2025-08-17",{"date":259,"type":260},"2025-08-19","ACTUAL",{"date":262,"type":260},"2024-01-11",{"date":264,"type":250},"2027-02-28",{"name":5,"class":6},13]