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临床试验/NCT07560709
NCT07560709No Longer Available不适用

Single-Patient Expanded Access Treatment Protocol for Use of RNA Loaded Lipid Particles (RNA-LPs) in a Patient With Recurrent Osteosarcoma

University of Florida1 个研究点 分布在 1 个国家开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
No Longer Available
试验地点
1

研究概览

简要总结

Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.

详细描述

The prognosis for patients with recurrent osteosarcoma and measurable disease is dismal and there are no FDA-approved therapies for this indication. A patient was enrolled on a clinical trial to develop a personalized pp65/tumor mRNA RNA-LP; however, the patient progressed following pp65 RNA-LP and had to be taken off treatment. Because the patient had not yet received personalized pp65/tumor mRNA RNA-LP, the IND sponsor treated the patient under an expanded access, individual patient protocol.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
15 Years 至 17 Years(Child)
性别
Male
接受健康志愿者
否

入选标准

  • •Participated in clinical trial
  • •Received pp65 RNA-LPs alone and had pp65/tumor mRNA RNA-LP manufactured
  • •Progressive disease prior to treatment with pp65/tumor mRNA RNA-LP

排除标准

  • •Diagnosis of recurrent OSA is not histopathologically confirmed (i.e. pseudoprogression)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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