NCT00004178已完成1 期
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven CEA expressing adenocarcinoma
- •Serum CEA levels greater than 10 ng/mL
- •Failed standard therapy
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Greater than 2 months
- •Hematopoietic:
- •Not specified
- •No significant hepatic disease
- •Bilirubin no greater than 3 mg/dL
- •No active clinical disease caused by hepatitis B
- •No significant renal disease
- •Creatinine no greater than 3 mg/dL
- •Cardiovascular:
- •No significant cardiovascular disease
- •No significant pulmonary disease
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant endocrine, rheumatologic, or allergic disease
- •No active clinical disease caused by cytomegalovirus or tuberculosis
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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