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Clinical Trials in China / NCT06219356
Recruiting Phase 1

A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas

NCT06219356 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou GluBio Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2024-01-11
Last updated
2025-08-19

Condition(s) studied

Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

GLB-002

GLB-002: Administered orally according to the assigned treatment schedule.

Study summary

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/R NHL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed. * 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: * Receipt of anticancer medications/therapies 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. * 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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Shanxi Cancer hospital Taiyuan Shanxi Recruiting
Tianjing Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
The First Affilicated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Hangzhou GluBio Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06219356 on ClinicalTrials.gov ↗ ← All trials in China