A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
NCT ID: NCT06219356
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
110 participants
INTERVENTIONAL
2024-01-11
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation of GLB-002 in Participants with R/R NHL-Phase 1a
Part 1a (Dose Escalation) of the study will enroll R/R 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/or recommended expansion doses (RED) in R/R NHL patients who are eligible for dose limiting toxicity (DLT) evaluation.
GLB-002
Administered orally according to the assigned treatment schedule.
Dose Expansion of GLB-002 in Participants with R/R 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/R Follicular Lymphoma (Grade 1、2、3a).
GLB-002
Administered orally according to the assigned treatment schedule.
Dose Expansion of GLB-002 in Participants with R/R 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/R Diffuse Large B-cell Lymphoma and R/R Follicular Lymphoma (Grade 3b).
GLB-002
Administered orally according to the assigned treatment schedule.
Dose Expansion of GLB-002 in Participants with other R/R 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/R NHL, including, but not limited to Mantle-cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Small Lymphocytic Lymphoma (SLL) /Chronic Lymphocytic Leukemia (CLL) and Peripheral T-cell Lymphoma (PTCL).
GLB-002
Administered orally according to the assigned treatment schedule.
Interventions
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GLB-002
Administered orally according to the assigned treatment schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants is ≥18 years of age at the time of signing the ICF.
* Participants with histopathologically or immunohistochemically confirmed NHL according to 2016 World Health Organization (WHO) haematolymphoid tumors criteria classification (CLL/SLL diagnosis according to 2018 IWCLL) who have failed standard of care therapy or lack an effective treatment regimen.
* Participants in Phase Ib screening period with measurable lesion, but no measurable nodal lesion limit for participants in Phase Ia.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
* Life expectancy \> 3 months.
* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.
* Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
* 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).
* 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.
* Participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.
* Participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy, or participants requiring treatment with systemic corticosteroids (\>10 mg/day 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.
* 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.
* Participants with known active leukemic involvement in central nervous system (CNS).
* Participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).
* 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
* QT interval interval \>470 milliseconds (ms) using electrocardiographic (ECG) at Screening.
* Participants has impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.
* Participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).
* Participants with known human immunodeficiency virus (HIV) infection.
* Participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases
* Participants with a condition that may affects the absorption, distribution, metabolism and excretion of GLB-002.
* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme (CYP)3A4/5 and/or P-glycoprotein (P-gp) within 7 days or 5 half-lives prior to the first dose of GLB-002, whichever is shorter.
* Participants who have undergone major surgery within 28 days prior to the first dose of the GLB-002.
* Pregnant or lactating women.
* 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.
* Participants,in the opinion of the Investigator, who are unsuitable to participate in the study.
18 Years
ALL
No
Sponsors
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Hangzhou GluBio Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Gang Lu, Ph.D.
Role: STUDY_DIRECTOR
Hangzhou GluBio Pharmaceutical Co., Ltd.
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Cancer hospital
Taiyuan, Shanxi, China
Tianjing Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hongmei Jing, MD
Role: primary
Bing Xu, MD
Role: primary
Guohui Cui, MD
Role: primary
Yajun Li, MD
Role: primary
Wei Yang, MD
Role: primary
Role: primary
Other Identifiers
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GLB-002-01
Identifier Type: -
Identifier Source: org_study_id
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