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临床试验/NCT00004178
NCT00004178已完成1 期

Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

Roger Williams Medical Center2 个研究点 分布在 1 个国家开始时间: 1998年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
试验地点
2

研究概览

简要总结

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

详细描述

OBJECTIVES:

  • Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
  • Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
  • Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
  • Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
  • Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

OUTLINE: This is a dose escalation study.

Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.

The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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