A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
Trial Parameters
Brief 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.