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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
Led by Hangzhou GluBio Pharmaceutical Co., Ltd. · Updated on 2025-08-19
110
Participants Needed
13
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GLB-002, an oral drug, in adults with relapsed or refractory Non-Hodgkin lymphomas (NHL) to assess its safety, how the body processes it, its effects on the body, and early signs of effectiveness. This first-in-human, open-label, phase 1 study includes participants who have not responded to standard treatments or lack effective options. The study is sponsored by Hangzhou GluBio Pharmaceutical Co., Ltd. and aims to identify appropriate dosing and tolerability in this patient population. The study has two main parts. Part 1a involves dose escalation to find the maximum tolerated dose and recommended doses by gradually increasing the dose in participants with relapsed or refractory NHL. Part 1b includes three dose expansion cohorts to confirm tolerability and evaluate efficacy in specific NHL subtypes: follicular lymphoma (Grade 1, 2, 3a), diffuse large B-cell lymphoma and follicular lymphoma (Grade 3b), and other NHL types such as mantle-cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia, and peripheral T-cell lymphoma. GLB-002 is taken orally following assigned schedules, and dosing can continue for up to two years. Participants will have regular assessments including monitoring for dose-limiting toxicities within 35 days of the first dose, adverse events, and response to treatment over up to two years. Pharmacokinetic studies of GLB-002 and its related compounds will be performed after single and multiple doses. Outcome measures include objective response rate, time to response, duration of response, progression-free survival, and overall survival. Safety is closely monitored through adverse event reporting and clinical evaluations throughout the treatment period.
CONDITIONS
Brief 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 procedures.
- Participants must be 18 years of age or older at the time of consent.
- Participants must have histopathologically or immunohistochemically confirmed Non-Hodgkin lymphoma according to 2016 WHO criteria or 2018 IWCLL for CLL/SLL.
- Participants must have relapsed or refractory disease after standard treatments or lack effective treatment options.
- Participants in Phase Ib must have measurable lesions; no lesion size limit for Phase Ia.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Life expectancy greater than 3 months.
- Good function of major organs including blood, liver, kidney, and coagulation.
- Willingness and ability to adhere to study visit schedules and protocol requirements.
You will not qualify if you...
- Receipt of anticancer therapies or CAR-T therapy within specified time frames before first dose of GLB-002.
- Participation in other investigational drug studies within 28 days prior to GLB-002 dosing, except certain survival follow-ups.
- Unresolved toxicities greater than Grade 1 from prior therapies, except alopecia or skin hyperpigmentation.
- Scheduled to receive other anticancer or investigational therapies during the study.
- Active graft versus host disease requiring systemic immunosuppressive treatment or recent systemic corticosteroid/immunosuppressive use.
- Recent autologous or allogeneic stem cell transplantation within specified time limits.
- Known active leukemic involvement in the central nervous system.
- Peripheral neuropathy of Grade 2 or higher.
- History or current active cancer other than specified exceptions within past 5 years.
- QT interval over 470 ms on ECG.
- Impaired cardiac function or significant cardiac disease within last 6 months.
- Known active hepatitis B, hepatitis C, or HIV infection.
- Life-threatening or uncontrolled active systemic infections unrelated to hematologic malignancy.
- Conditions affecting drug absorption, distribution, metabolism, or excretion.
- Use of strong/moderate CYP3A4/5 or P-glycoprotein inhibitors/inducers within 7 days before dosing.
- Major surgery within 28 days prior to first dose.
- Pregnant or lactating women.
- Cognitive impairment limiting understanding or compliance.
- Investigator judgment deeming participant unsuitable for study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years (each cycle is 28 days)
Participants receive the study drug GLB-002 orally according to the assigned treatment schedule to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
Repeated visits for dosing and assessments during each 28-day cycle for up to 2 years
Trial Site Locations
Total: 13 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
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2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
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4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
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6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
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7
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
8
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
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9
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
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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
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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