A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- MorphoSys AG
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events (AEs)
研究概览
简要总结
This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
详细描述
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee.
An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
tafasitamab (MOR208) in combination with idelalisib
干预措施: Tafasitamab (Biological)
Cohort A
tafasitamab (MOR208) in combination with idelalisib
干预措施: Idelalisib (Drug)
Cohort B
tafasitamab (MOR208) in combination with venetoclax
干预措施: Tafasitamab (Biological)
Cohort B
tafasitamab (MOR208) in combination with venetoclax
干预措施: Venetoclax (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs)
时间窗: 2 years
For details please see Section of Adverse Events Overview
次要结局
- Maximum Plasma Concentration (Cmax) of MOR00208(At Cycle 3 Day 15)
- Best Objective Response Rate (ORR)(2 years)
- Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation(2 years)