Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Adaptimmune
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Adverse Events Related to Study Treatment
研究概览
简要总结
The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and bad) of genetically modified T cells after chemotherapy on your cancer and general health.
详细描述
Purpose of this study is to evaluate the safety and tolerability of autologous genetically modified T cells. Genetic material is transferred into the subject's previously harvested autologous T cells to redirect them to target melanoma cells rather than their usual target. Study subjects must have histologically or cytologically melanoma stage 3/4 and their tumor must express HLA Class 1 allele HLA-A*0201 for NY-ESO-1/LAGE. Subjects must also have measureable disease on study entry, as defined by at least one lesion that can be measured in at least one dimension >= 10mm with spiral CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NY-ESO-1/LAGE-1 and HLA-A*02 Positive Subjects
干预措施: Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T (Genetic)
结局指标
主要结局
Adverse Events Related to Study Treatment
时间窗: Up to 12 months
Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
次要结局
- Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.(8 Weeks post T-cell infusion)
- Tumor Response(Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11)
- Peak Persistence of Modified T-cells in the Peripheral Blood(Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU)