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临床试验/NCT04135092
NCT04135092No Longer Available不适用

Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

National Institutes of Health Clinical Center (CC)0 个研究点开始时间: 2019年10月22日最近更新:
相关药物

试验速览

阶段
不适用
状态
No Longer Available

研究概览

简要总结

Single Patient Expanded Access

详细描述

Background:

Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.

Objective:

Under Individual Patient Expanded Access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer.

Eligibility:

研究设计

研究类型
Expanded Access

入排标准

接受健康志愿者

入选标准

  • Measurable (per RECIST v1.1 criteria), metastatic prostate cancer.
  • Refractory to approved standard systemic therapy.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Willing to sign a Durable Power of Attorney Form.
  • Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
  • Subject must be co-enrolled on protocol 03-C-0277.

排除标准

  • Not applicable.

研究者

申办方类型
Nih
责任方
Sponsor

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