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Non-Hodgkin LymphomaPhase 1NCT06219356

A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas

A Phase 1 study testing GLB-002 in people with Non-Hodgkin Lymphoma, run by Hangzhou GluBio Pharmaceutical Co., Ltd. at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
GLB-002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
13 sitesChina
Study dates
11 Jan 2024to 28 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Liu, MD contact

86-18616699599

Jing.Liu@glubiotx.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yuqing Song, MD, 86-010-88121122, songyuqin622@163.com

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Hongmei Jing, MD, 86-010-82266699

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Yajun Li, MD, 86-0731-88651900

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhiming Li, MD, 86-020-87343088, lizhm@sysucc.org.cn

    Recruiting

  • The First Affilicated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Hongyan Tong, MD, 86-0571-87236114, tonghongyan@zju.edu.cn

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Yuerong Shuang, MD, 86-0791-88315120, shuangyr63@163.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jian Zhang, MD, 86-021-64175590, syner2000@163.com

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Wei Yang, MD, 86-024-23896615

    Recruiting

  • Shanxi Cancer hospital

    Taiyuan, Shanxi, 030000

    86-0351-4881611

    Recruiting

  • Tianjing Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300020

    Lihua Qiu, MD, 86-022-23109106, JZXQLH@163.com

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

    Guohui Cui, MD, 86-027-85726114

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Bing Xu, MD, 86-0592-2132222

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Keshu Zhou, MD, 86-0371-65587320, drzhouks77@163.com

    Quande Lin, MD

    Recruiting

Other trials in China

About this study

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)

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).

Being tested
GLB-002
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLB-002Drug

    Also called GLB-A062-B

    Administered orally according to the assigned treatment schedule.

Study groups in NCT06219356
Study groupRoleWhat they receive
Dose Escalation of GLB-002 in Participants with R/R NHL-Phase 1aExperimentalPart 1a (Dose Escalation) of the study will enroll R/R NHL participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-002 administered orally, and determine the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in R/R NHL patients who are eligible for dose limiting toxicity (DLT) evaluation.
Receives: Drug: GLB-002
Dose Expansion of GLB-002 in Participants with R/R FL (Grade 1, 2, 3a)-Phase 1b Cohort 1ExperimentalPart 1b (Dose Expansion) Cohort 1 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R Follicular Lymphoma (Grade 1、2、3a).
Receives: Drug: GLB-002
Dose Expansion of GLB-002 in Participants with R/R DLBCL and FL (Grade 3b)-Phase 1b Cohort 2ExperimentalConfirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R Diffuse Large B-cell Lymphoma and R/R Follicular Lymphoma (Grade 3b).
Receives: Drug: GLB-002
Dose Expansion of GLB-002 in Participants with other R/R NHL-Phase 1b Cohort 3ExperimentalPart 1b (Dose Expansion) Cohort 3 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for other R/R NHL, including, but not limited to Mantle-cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Small Lymphocytic Lymphoma (SLL) /Chronic Lymphocytic Leukemia (CLL) and Peripheral T-cell Lymphoma (PTCL).
Receives: Drug: GLB-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicity (DLT)

    DLT is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period, except those that are clearly and incontrovertibly due to extraneous causes including disease progression, pre-existing medical condition that has not worsened from baseline, or other causes that are clearly not due to study drug.

    Measured: Up to 35 days after first dose of study treatment in Phase 1a

  2. Maximum Tolerated Dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 of 6 DLT-evaluable participants experienced a DLT.

    Measured: Up to 2 years (each cycle is 28 days)

  3. Recommended Expansion Doses (RED)

    RED will be decided by safety review committee (SRC) considering the data including safety, tolerability, PK, PD, and preliminary efficacy of GLB-002 in dose escalation. RED will be the dose level below MTD.

    Measured: Up to 2 years (each cycle is 28 days)

  4. Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs)

    AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AE will be graded according to the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) version 5.0.

    Measured: Up to 2 years

  5. Recommended Phase 2 Dose (RP2D)

    RP2D based on the totality of data across dosing cohorts in the dose escalation and expansion phases of the study including PK, PD, safety and efficacy outcomes.

    Measured: Up to 2 years

  6. Objective Response Rate (ORR)

    ORR is defined as the percent of participants whose best overall response is complete response (CR) or partial response (PR). CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 International Working Group Criteria for Chronic Lymphocyte Leukemia (2018 IWCLL).

    Measured: Up to 2 years

  7. Time to Response (TTR)

    For participants with objective response, TTR was defined as the time of participants from the first treatment administration to the first incidence of a confirmed CR or PR was reported. CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL.

    Measured: Up to 2 years

  8. Duration of Remission or Response (DOR)

    For participants with objective response, DOR is measured from the time of any of CR or PR are first met (whichever is first recorded) until the first date at which progressive disease or death from any cause is objectively documented assessment. CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL.

    Measured: Up to 2 years

  9. Progression-free Survival (PFS)

    PFS is defined as the time from the first dose of GLB-002 to the first occurrence of progressive disease (PD) or death from any cause. PD will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL.

    Measured: Up to 2 years

  10. Overall Survival (OS)

    OS is defined as the time from the first dose of GLB-002 to death due to any cause.

    Measured: Up to 2 years

Secondary outcomes (21)

  1. GLB-002 and GLB-A062-A (R-enantiomers of GLB-002) Pharmacokinetics after Single Administration-AUC0-last

    Area under the concentration-time curve from zero to the last measurable concentration

    Measured: Up to 48 hours after single administration

  2. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-AUC0-24

    Area under the concentration-time curve from 0 to 24 hours

    Measured: Up to 48 hours after single administration

  3. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-AUC0-inf

    Area under the concentration-time curve from 0 to infinity

    Measured: Up to 48 hours after single administration

  4. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Cmax

    Maximum plasma concentration

    Measured: Up to 48 hours after single administration

  5. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Tmax

    The time to reach maximum concentration

    Measured: Up to 48 hours after single administration

  6. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-T1/2

    Terminal half-life

    Measured: Up to 48 hours after single administration

  7. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Vz/F

    Apparent volume of distribution

    Measured: Up to 48 hours after single administration

  8. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-CL/F

    Apparent total clearance of the drug from plasma after oral administration

    Measured: Up to 48 hours after single administration

  9. GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-λz

    Terminal rate constant

    Measured: Up to 48 hours after single administration

  10. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Tmax,SS

    Time of maximum concentration at steady state

    Measured: Up to 2 years

  11. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cav,SS

    Average plasma concentration at steady state

    Measured: Up to 2 years

  12. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cmax,SS

    Maximum plasma concentration at steady state

    Measured: Up to 2 years

  13. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cmin,SS

    Minimum plasma concentration at steady state

    Measured: Up to 2 years

  14. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-AUC0-tau

    Area under the concentration-time curve during the dosing interval

    Measured: Up to 2 years

  15. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-λz

    Terminal rate constant

    Measured: Up to 2 years

  16. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Vz/F

    Apparent volume of distribution

    Measured: Up to 2 years

  17. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-CLSS/F

    Apparent clearance at steady state

    Measured: Up to 2 years

  18. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-T1/2

    Terminal half-life

    Measured: Up to 2 years

  19. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Rac [AUC]

    Accumulation index in area under the concentration-time curve

    Measured: Up to 2 years

  20. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Rac [Cmax]

    Accumulation index in maximum plasma concentration

    Measured: Up to 2 years

  21. GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-DF

    Degree of fluctuation index

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start11 Jan 2024
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219356
Sponsor's protocol ID
GLB-002-01
Status last verified
Jun 2025
First submitted
22 Dec 2023
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLB-002 in people with Non-Hodgkin Lymphoma, run by Hangzhou GluBio Pharmaceutical Co., Ltd. at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jing Liu, MD (86-18616699599, Jing.Liu@glubiotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicity (DLT) (time frame: Up to 35 days after first dose of study treatment in Phase 1a). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06219356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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