Multicenter, Open Label, Phase I Study of Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
研究概览
简要总结
The main objective of this clinical study is to evaluate the safety and tolerability of NK-92/5.28.z and to determine the maximum tolerated dose or maximum feasible dose (MFD). Recommended phase 2 doses both for intraoperative injections only (RP2Diio) and repetitive injections (RP2Dri) will be determined. Frequent side effects and target organs of toxicity and their severity, duration and reversibility will be determined. Furthermore, pharmacokinetics and pharmacodynamics will be examined. In addition, potential signs of anti-tumor activity of NK-92/5.28.z cells will be analyzed. In the separate "CAR2BRAIN-Check" cohort, combination therapy of NK-92/5.28.z with the anti-PD-1 antibody Ezabenlimab (BI 754091) will be tested.
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 65+ years（65+ Years, 18-64 Years）
- 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
NK-92/5.28.z + Ezabenlimab
Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8; intravenous infusion of Ezabenlimab 240mg q 3 weeks
干预措施: NK-92/5.28.z (Biological)
NK-92/5.28.z + Ezabenlimab
Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8; intravenous infusion of Ezabenlimab 240mg q 3 weeks
干预措施: Ezabenlimab (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
时间窗: 24 weeks
Period of detectability of NK-92/5.28.z cells in blood and cerebrospinal fluid (CSF) during the first 24 weeks after NK-92/5.28.z application with qPCR.
时间窗: 24 weeks
qPCR detection of NK-92/5.28.z in blood or CSF
Cytokine profile in the blood and the cerebrospinal fluid.
时间窗: 24 weeks
Maximum tolerated dose (MTD) or maximum feasible dose (MFD) for NK-92/5.28.z
时间窗: 24 weeks
次要结局
- Progression-free survival.(24 weeks)
- Objective response rate.(24 weeks)
- NK-92- and/or CAR 5.28.z-directed immune response.(24 weeks)
- Overall survival.(24 weeks)
研究者
Dr. Senckenberg Institute of Neurooncology
Scientific
Goethe University Frankfurt