jRCT2080225077已完成1 期
A PHASE I STUDY OF RO7082859 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, dose escalation
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •CD20 positive B cell NHL that is recurrent or refractory to standard therapy or for which no standard therapy exists.
- •Pathologically confirmed B cell NHL.
- •ECOG PS of 0 or
- •Life expectancy =>12 weeks from the date of enrollment.
- •Major organ function meets all criteria.
排除标准
- •Pregnant or lactating woman.
- •Current or previous autoimmune disease.
- •Positive test result for human immunodeficiency virus antibody, hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- •Current or previous clinically significant liver disease.
- •Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- •History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
结局指标
主要结局
-
safety pharmacokinetics other other(DLT) NCI CTCAE
次要结局
未报告次要终点
研究者
研究点 (1)
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