NCT05518318尚未招募3 期
Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Life expectancy of ≥ 12 weeks.
- •Have adequate hematologic and organ function .
排除标准
- •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.
研究组 & 干预措施
GLS-010
Experimental
GLS-010 therapy
干预措施: GLS-010 (Drug)
chemotherapy
Active Comparator
chemotherapy
干预措施: Chemotherapy of Investigator's choice (Drug)
结局指标
主要结局
Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014
时间窗: Up to 2 years
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
次要结局
- 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)
- 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)
- Objective Response Rate (ORR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
研究者
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