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

Last updated: August 27, 2024
Sponsor: Hangzhou GluBio Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Cancer

Non-hodgkin's Lymphoma

Lymphoma

Treatment

GLB-002

Clinical Study ID

NCT06219356
GLB-002-01
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: GLB-002
Phase: 1
Study Start date:
January 11, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Tianjing Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • The First Affilicated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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