GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)
- Conditions
- Refractory Classic Hodgkin LymphomaRecurrent Classic Hodgkin LymphomaClassic Hodgkin's Lymphoma
- Interventions
- Drug: Chemotherapy of Investigator's choice
- Registration Number
- NCT05518318
- Lead Sponsor
- Guangzhou Gloria Biosciences Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Signed written informed consent form (ICF).
- Age of ≥ 18 years at the time of enrollment.
- Histologically confirmed classic Hodgkin's lymphoma (cHL).
- Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
- Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
- Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks.
- Have adequate hematologic and organ function .
Key
- Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
- Central nervous system lymphoma invasion.
- Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
- 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.
- Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- 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.
- 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).
- Pregnant or breast-feeding women.
- Patients are unsuitable for the study evaluated by investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description chemotherapy Chemotherapy of Investigator's choice chemotherapy GLS-010 GLS-010 GLS-010 therapy
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014 Up to 2 years Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR) DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first Up to 2 years
Time to Response (TTR) TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014 Up to 2 years
Objective Response Rate (ORR) Up to 2 years ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.
Overall Survival (OS) Up to 2 years Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason
Disease Control Rate (DCR) Up to 2 years DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.