A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 202
- 主要终点
- Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
研究概览
简要总结
The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
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
- •Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).
- •PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.
- •Has adequate bone marrow reserves and organ functions.
排除标准
- •History of central nervous system (CNS) metastases or active CNS involvement.
- •Received prior systemic anticancer therapy within 4 weeks before randomization.
- •Received prior ani-CD47 or SIRPa treatment.
- •History of human immunodeficiency virus (HIV).
- •Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- •History of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.
研究组 & 干预措施
Physician's Choice Chemotherapy
Participants will receive physician's choice of either bendamustine or gemcitabie.
Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles.
Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles.
干预措施: Bendamustine (Drug)
IMM01 plus Tiselizuma
Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years.
干预措施: Tislelizumab (Biological)
IMM01 plus Tiselizuma
Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years.
干预措施: IMM01 (Biological)
Physician's Choice Chemotherapy
Participants will receive physician's choice of either bendamustine or gemcitabie.
Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles.
Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
时间窗: approximately 24 months
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(approximately 36 months)
- Number of Participants Who Experienced At Least One Adverse Event (AE)(approximately 18 months)
- Duration of Response (DOR)(approximately 24 months)