A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Comparison of frequency, phenotype and transcriptional profile of the different immune subsets in the tumor following adoptive cell therapy infusion using spectral flow cytometry and RNA sequencing
研究概览
简要总结
This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.
The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated to a social security regimen
- •Tumor lesion accessible to core biopsies
- •Patient who is fully informed, able to comply with the protocol and who signed the informed consent
- •Pediatric patients > than 2 years old can be included
- •No restriction about the Eastern Cooperative Oncology Group (ECOG) status
排除标准
- •Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples).
- •Tumor lesion not accessible to core biopsies.
- •Pregnant or nursing women cannot participate in this study.
结局指标
主要结局
Comparison of frequency, phenotype and transcriptional profile of the different immune subsets in the tumor following adoptive cell therapy infusion using spectral flow cytometry and RNA sequencing
时间窗: 3 months following ACT
次要结局
- Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0(From enrollment to 30 days after the last sample)
- Objective Response(3 months following ACT)
- Progression-free survival(5 years after first ACT infusion)
- Overall survival(5 years after first ACT infusion)