NCT05100316终止2 期
A Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants With Solid Tumors and Hematologic Malignancies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
研究概览
简要总结
This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .
- •Participant must be greater than or equal to (>=)18 years of age (or >=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma [MRCLS])
- •Participants with life expectancy of greater than 6 months
- •Performance status: Eastern Cooperative Oncology Group 0-1.
排除标准
- •Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
- •Prior malignancy not in complete remission.
- •Clinically significant systemic illness
- •Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,
- •Prior or active demyelinating disease
- •Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.
- •Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.
结局指标
主要结局
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
时间窗: Up to 2 weeks
Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous.
次要结局
未报告次要终点
研究者
研究点 (4)
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