Testing GLB-002 for patients with relapsed or refractory Non-Hodgkin Lymphomas
Official title: 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 (R/R NHL)
Run by Hangzhou GluBio Pharmaceutical Co., Ltd. · NCT06219356 · Data updated 2026-11-12
This study is testing a new treatment called GLB-002 to see if it can help people with Non-Hodgkin lymphoma who haven't had success with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Hangzhou GluBio Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy, prednisone |
| Locations | 13 sites (Beijing, Beijing Municipality and 12 other locations) |
| Status | Recruiting |
| Started | January 11, 2024 |
| Main results expected | January 31, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT06219356 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with relapsed or refractory Non-Hodgkin lymphoma who have failed standard treatment options.
✕Probably not a fit
Patients with early-stage Non-Hodgkin lymphoma or those who have not yet undergone standard treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a first-in-human, phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GLB-002 as a monotherapy in patients with relapsed or refractory Non-Hodgkin lymphomas. The study will involve dose escalation and expansion phases to determine the optimal dosing and effects of the treatment. Participants must have confirmed diagnoses of Non-Hodgkin lymphoma and have previously failed standard therapies.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat Non-Hodgkin lymphomas.
How similar studies have gone: While this approach is novel in the context of GLB-002, similar studies targeting Non-Hodgkin lymphoma have shown promise with other investigational therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China Recruiting -
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China Recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Recruiting -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Show 7 more locations
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Hunan Cancer Hospital
Changsha, Hunan, China Recruiting -
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China Recruiting -
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting -
Shanxi Cancer hospital
Taiyuan, Shanxi, China Recruiting -
Tianjing Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China Recruiting -
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jing Liu, MD
- Email: Jing.Liu@glubiotx.com
- Phone: 86-18616699599
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.