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

GluBio Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Non-Hodgkin Lymphoma

Treatments: Drug: GLB-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT06219356

GLB-002-01

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

Dose Escalation of GLB-002 in Participants with R/R NHL-Phase 1a

Experimental group

Description:

Part 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.

Treatment:

Drug: GLB-002

Dose Expansion of GLB-002 in Participants with R/R FL (Grade 1, 2, 3a)-Phase 1b Cohort 1

Experimental group

Description:

Part 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).

Treatment:

Drug: GLB-002

Dose Expansion of GLB-002 in Participants with R/R DLBCL and FL (Grade 3b)-Phase 1b Cohort 2

Experimental group

Description:

Confirm 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).

Treatment:

Drug: GLB-002

Dose Expansion of GLB-002 in Participants with other R/R NHL-Phase 1b Cohort 3

Experimental group

Description:

Part 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).

Treatment:

Drug: GLB-002