NCT02945215已完成1 期
A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 12
- 主要终点
- AUC0-inf of IBI301 and rituximab
研究概览
简要总结
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20-positive B-cell lymphoma.
- •18 years to 65 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Signed an informed consent.
- •Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.
排除标准
- •Participation in another interventional clinical trial in the past 28 days.
- •Known allergic reactions against monoclonal antibody or rituximab.
- •Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
- •Blood concentration of Rituximab>24ug/ml.
- •HIV positive patients.
- •HCV antigen and antibody positive.
- •Acute and chronic hepatitis B virus infection.
研究组 & 干预措施
IBI301
Experimental
干预措施: IBI301 (Drug)
Rituximab
Active Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
AUC0-inf of IBI301 and rituximab
时间窗: 91 days
次要结局
- Peak Plasma Concentration (Cmax)(91 days)
- AUC（0-t） of IBI301 and rituximab(91 days)
- Percentage and absolute value of CD19+(91 days)
- Safety profiles(up to 1 year)
- Area under the plasma concentration versus time curve (AUC)(91days)
- Percentage and absolute value of CD20+ B-cell(91 days)
- Positive rate of ADA(91 days)
- Positive rate of NAb(91 days)
研究者
研究点 (12)
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