a study of glb-002 in patients with relapsed or refractory non-hodgkin lymphomas

Conditions: Non-Hodgkin Lymphoma

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 non-hodgkin lymphomas (r/r nhl).


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.