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Trial Title:
GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)
NCT ID:
NCT05518318
Condition:
Classic Hodgkin's Lymphoma
Recurrent Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Conditions: Keywords:
GLS-010
relapsed or refractory classic Hodgkin's lymphoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GLS-010
Description:
Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W
Arm group label:
GLS-010
Other name:
GLS-010 therapy
Intervention type:
Drug
Intervention name:
Chemotherapy of Investigator's choice
Description:
Chemotherapy administered as assessed as appropriate by the investigator in accordance
with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and
GVD
Arm group label:
chemotherapy
Summary:
The primary objective of this study is to evaluate the efficacy of GLS-010 in
participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as
measured by Progression-free Survival (PFS) as assessed by IRRC
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Signed written informed consent form (ICF).
2. Age of ≥ 18 years at the time of enrollment.
3. Histologically confirmed classic Hodgkin's lymphoma (cHL).
4. Subjects required Relapsed or refractory ,failure to at least 2 lines of prior
systemic chemotherapy.
5. Patients who have failed prior vibutuximab treatment or are unwilling or not
eligible for vibutuximab treatment
6. Have at least one measurable lesion according to Lugano classification 2014 and
FDG-PET was positive.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Life expectancy of ≥ 12 weeks.
9. Have adequate hematologic and organ function .
Key Exclusion Criteria:
1. Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
2. Central nervous system lymphoma invasion.
3. Subjects requiring systemic corticosteroids or other immunosuppressive agents within
14 days prior to screening or during the study period.
4. Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4
antibody, or any other antibody or drug target for T cell co-stimulatory or
checkpoint pathways.
5. Known human immunodeficiency virus (HIV), or serologic status reflecting active
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
6. Subjects with other malignancy within 5 years prior to the first dose of study
treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of
the skin.
7. Have received chemotherapy, radiotherapy, molecular-targeted therapy or major
surgery within 4 weeks prior to the first dose of study treatmen; Clinically
significant AE associated with previous treatment has not returned to baseline or ≤1
(except hair loss).
8. Pregnant or breast-feeding women.
9. Patients are unsuitable for the study evaluated by investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Gloria Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518318
