Status:
RECRUITING
A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
Lead Sponsor:
Hangzhou GluBio Pharmaceutical Co., Ltd.
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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),...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06219356
Start Date
January 11 2024
End Date
February 28 2027
Last Update
August 19 2025
Active Locations (13)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060