NCT04110301招募中1 期
A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an Objective Response of Complete Response
研究概览
简要总结
This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
详细描述
The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients, >=18 years of age;
- •Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
- •Evidence of progression or lack of response following at least 1 prior treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm
- •Adequate hematologic function (unless abnormalities are related to NHL)
- •Life expectancy >6 months
- •Able and willing to provide written informed consent and to comply with the study protocol
排除标准
- •Evidence ongoing transformation into aggressive NHL
- •Central nervous system lymphoma
- •Patients with progressive multifocalleukoencephalopathy (PML)
- •Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
- •Prior use of any anti-cancer vaccine
- •Prior administration of radiotherapy 42 days prior to study entry
- •Prior administration of chemotherapy 28 days prior to study entry
- •History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- •Known hypersensitivity to thalidomide or lenalidomide
- •Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
- •Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- •Pregnant or lactating females
研究组 & 干预措施
MIL62 + Lenalidomide
Experimental
MIL62 plus Lenalidomide
干预措施: Recombinant Humanized Monoclonal Antibody MIL62 Injection (Drug)
MIL62 + Lenalidomide
Experimental
MIL62 plus Lenalidomide
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Percentage of Participants With an Objective Response of Complete Response
时间窗: Baseline to 1 month after the last dose of last patient
Percentage of Participants With an Objective Response of Complete Response
次要结局
- Number of Participants With Treatment Emergent Adverse Events(up to the 1 month the last dose of last subject)
- Kaplan-Meier Estimate of Duration of Response(Baseline to 1 month after the last dose of last patient)
- Percentage of Participants With Disease Control(Baseline to 1 month after the last dose of last patient)
- Participants With 1 Year Progression Free Survival(Baseline to 1 month after the last dose of last patient)
研究者
研究点 (1)
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