NCT04103905已完成1 期
A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability，Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年2月10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
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
研究概览
简要总结
This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.
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;
- •Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy >6 months
- •Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments
- •Able and willing to provide written informed consent and to comply with the study protocol
排除标准
- •Prior use of any investigational antibody therapy within 3 months of study start
- •Prior use of any anti-cancer vaccine
- •Prior administration of radioimmunotherapy 3 months prior to study entry
- •Central nervous system lymphoma
- •History of other malignancy
- •Evidence of significant, uncontrolled concomitant disease
- •Abnormal laboratory values
- •Patients with progressive multifocalleukoencephalopathy (PML)
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- •Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
研究组 & 干预措施
MIL62
Experimental
干预措施: Recombinant Humanized Monoclonal Antibody MIL62 Injection (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
时间窗: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
次要结局
- Overall Survival (OS) in the Study(by the end of the follow-up period of the study)
- Participants With Event-Free Survival (EFS)(by the end of the follow-up period of the study)
- Percentage of Participants With Best Overall Response(by the end of Cycle 8 (each cycle is 28 days))
- Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62(by the end of Cycle 4 (each cycle is 28 days))
- Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State(by the end of Cycle 4 (each cycle is 28 days))
- Change in Cluster of Differentiation 19 (CD19+) B Cells(by the end of Cycle 4 (each cycle is 28 days))
- Percentage of Participants with Positive Anti-Drug Antibodies to MIL62(by the end of Cycle 4 (each cycle is 28 days))
- Duration of response (DoR)(by the end of the follow-up period of the study)
- Systemic Clearance of MIL62 Under Steady State(by the end of Cycle 4 (each cycle is 28 days))
- Volume of Distribution Under Steady State (Vss) of MIL62(by the end of Cycle 4 (each cycle is 28 days))
- Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State(by the end of Cycle 4 (each cycle is 28 days))
- Progression-free Survival (PFS) in the Study(by the end of the follow-up period of the study)
- Disease control rate (DCR)(by the end of the follow-up period of the study)
- Change in Cluster of Differentiation 20 (CD20+) B Cells(by the end of Cycle 4 (each cycle is 28 days))
研究者
研究点 (1)
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