Phase
Condition
Hematologic Cancer
Non-hodgkin's Lymphoma
Lymphoma
Treatment
GLB-002
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 NHLaccording to 2016 World Health Organization (WHO) haematolymphoid tumors criteriaclassification (CLL/SLL diagnosis according to 2018 IWCLL) who have failed standardof care therapy or lack an effective treatment regimen.
Participants in Phase Ib screening period with measurable lesion, but no measurablenodal 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 otherprotocol requirements.
Exclusion
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 antigenreceptor 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 withinthe last 28 days or 5 half-lives, whichever is shorter, prior to the first dose ofGLB-002 (exception of participants who participated in only one investigational drugstudy with overall survival follow-up).
Participants with unresolved clinically significant toxicities of > Grade 1 AE ornot be recovered to baseline value from prior anticancer therapies with exception ofalopecia or hyperpigmentation of the skin.
Participants who are scheduled to receive other anticancer therapies or otherinvestigational drugs during the study period.
Participants with active acute or chronic graft versus host disease (GVHD) requiringsystemic immunosuppressive therapy, or participants requiring treatment withsystemic corticosteroids (>10 mg/day prednisone or equivalent) or otherimmunosuppressive drugs within the last 7 days prior to the first dose of GLB-002 orduring the study period.
Receipt of Autologous Stem Cell Transplantation (ASCT) within the last 3 months, orallogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6months 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 theexception of curatively resected cancer in situ, including cervical carcinoma insitu, basal cell carcinoma of the skin, or prostate cancer in situ, etc
QT interval interval >470 milliseconds (ms) using electrocardiographic (ECG) atScreening.
Participants has impaired cardiac function or clinically significant cardiac diseaseat current or within last 6 months.
Participants with known active infection of hepatitis B virus (HBV) or hepatitis Cvirus C (HCV).
Participants with known human immunodeficiency virus (HIV) infection.
Participants with known life-threatening or clinical significant uncontrolled activesystemic 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 orinducers 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 doseof the GLB-002.
Pregnant or lactating women.
Participants who have cognitive impairment due to any psychiatric or neurologicalcondition, 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 participatein the study.
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaActive - Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330029
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Tianjing Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300020
ChinaActive - Recruiting
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
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