Actively Recruiting
A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
Led by Hangzhou GluBio Pharmaceutical Co., Ltd. · Updated on 2025-08-19
110
Participants Needed
13
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand and voluntarily sign a written informed consent form prior to any study-related assessments or procedures.
- Participants must be 18 years of age or older at the time of signing the consent form.
- Participants must have histopathologically or immunohistochemically confirmed Non-Hodgkin lymphoma per 2016 WHO criteria or CLL/SLL diagnosis per 2018 IWCLL.
- Participants must have failed standard of care therapy or lack an effective treatment regimen.
- Participants in Phase Ib must have measurable lesions; no limit on measurable nodal lesions for Phase Ia.
- Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, or 2.
- Life expectancy must be greater than 3 months.
- Participants must have good major organ function including hematology, liver, kidney, and coagulation.
- Participants must be willing and able to adhere to the study visit schedule and protocol requirements.
You will not qualify if you...
- Receipt of anticancer medications or therapies such as chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal agents within 28 days or 5 half-lives before first GLB-002 dose; CAR-T therapy within 3 months.
- Currently enrolled in another investigational drug study or participated within 28 days or 5 half-lives before first GLB-002 dose (except for one investigational drug study with overall survival follow-up).
- Unresolved clinically significant toxicities greater than Grade 1 adverse events from prior therapies, except alopecia or skin hyperpigmentation.
- Scheduled to receive other anticancer therapies or investigational drugs during the study.
- Active acute or chronic graft versus host disease requiring systemic immunosuppressive therapy or systemic corticosteroids over 10 mg/day prednisone or equivalent within last 7 days or during study.
- Autologous stem cell transplant within last 3 months or allogeneic hematopoietic stem cell transplant within last 6 months before first GLB-002 dose.
- Known active leukemic involvement in the central nervous system.
- Peripheral neuropathy Grade 2 or higher.
- History or current active cancer other than NHL within past 5 years, except certain curatively resected in situ cancers.
- QT interval greater than 470 milliseconds on ECG at screening.
- Impaired cardiac function or significant cardiac disease currently or within last 6 months.
- Known active infection with hepatitis B virus, hepatitis C virus, or HIV.
- Life-threatening or clinically significant uncontrolled active systemic infections unrelated to hematologic malignancies.
- Conditions affecting absorption, distribution, metabolism, or excretion of GLB-002.
- Use of strong or moderate inhibitors or inducers of CYP3A4/5 or P-glycoprotein within 7 days or 5 half-lives before first GLB-002 dose.
- Major surgery within 28 days prior to first GLB-002 dose.
- Pregnant or lactating women.
- Cognitive impairment due to psychiatric or neurological conditions that may limit study compliance.
- Investigator's opinion deeming participant unsuitable for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Actively Recruiting
7
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
8
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
9
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
12
Tianjing Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
13
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jing Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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