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

Exclusion Criteria20

• 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.