NCT04642937进行中（未招募）1 期
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
OX2 Therapeutics1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年12月1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
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
研究概览
简要总结
This is a single-center, open-label, dose-range finding Phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Aged 18 years and older.
- •Confirmed diagnosis of GBM.
- •Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device).
- •Tumor debulking or biopsies may be performed to clinical trial enrollment if indicated and feasible.
排除标准
- •Bevacizumab or targeted therapy within 45 days of enrollment.
- •Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease).
- •Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy.
- •History of Gliadel water, GammaTile or other implanted therapeutic agent.
- •Concurrent use of tumor treatment field devices (e.g. Optune).
研究组 & 干预措施
hP1A8
Experimental
Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort.
干预措施: Treatment with hP1A8 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
时间窗: 12 months
次要结局
- Incidence of serious adverse events (SAEs)(12 months)
- Time to progression (TTP)(24 months)
- Overall survival (OS)(24 months)
- Progression free survival (PFS)(24 months)
研究者
研究点 (1)
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