Clinical trial Recruiting at 13 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment110 (estimated)
SponsorHangzhou GluBio Pharmaceutical Co., Ltd.
Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor, chemotherapy, immunotherapy, prednisone
Locations13 sites (Beijing, Beijing Municipality and 12 other locations)
StatusRecruiting
StartedJanuary 11, 2024
Main results expectedJanuary 31, 2026
Study endsFebruary 28, 2027
Registry record updatedAugust 19, 2025
Trial IDNCT06219356 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.