Testing GLB-002 for patients with relapsed or refractory Non-Hodgkin Lymphomas

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)

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
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• 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)
• Trial ID: NCT06219356 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory Non-Hodgkin lymphoma who have failed standard treatment options.

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.

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 performed: While this approach is novel in the context of GLB-002, similar studies targeting Non-Hodgkin lymphoma have shown promise with other investigational therapies.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 12 other locations

• 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)
• 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

Conditions Non-Hodgkin Lymphoma