A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Complete remission rate(CRR) as Assessed by Investigator
研究概览
简要总结
This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
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
- Double (Participant, Investigator)
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •At least one measurable lesion (as per Lugano 2014 criteria).
- •Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
- •Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
- •Adequate hepatic, hematologic, and renal function.
- •Expected survival at least 6 months.
排除标准
- •Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
- •History of central nervous system (CNS) metastases or active CNS involvement.
- •History of other malignancy within the past 5 years.
- •Severe organic cardiovascular or cerebrovascular diseases.
- •History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
- •Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
- •Human immunodeficiency virus (HIV) infection.
- •Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
- •Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
研究组 & 干预措施
IMM0306 in combination with lenalidomide
One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.
干预措施: IMM0306 2.0 mg/kg (Drug)
IMM0306 in combination with lenalidomide
One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.
干预措施: Lenalidomide 20 mg (Drug)
Placebo in combination with lenalidomide
One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.
干预措施: Placebo (Drug)
Placebo in combination with lenalidomide
One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.
干预措施: Lenalidomide 20 mg (Drug)
结局指标
主要结局
Complete remission rate(CRR) as Assessed by Investigator
时间窗: approximately 48 months
CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Progression-Free Survival (PFS) as Assessed by Investigator
时间窗: approximately 48 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
- Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)(approximately 48 months)
- Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)(approximately 48 months)
- Objective Response Rate (ORR)(approximately 48 months)
- Duration of Response (DOR)(approximately 48 months)
- Overall Survival (OS)(approximately 60 months)
- Time to Next Anti-Lymphoma Treatment(TTNT)(approximately 48 months)
- Adverse Event (AE)(approximately 48 months)