评估实体瘤和血液肿瘤过继细胞疗法 (ACT) 反应的免疫决定因素的探索性研究 (PIONEER)
评估实体瘤和血液肿瘤中过继细胞疗法 (ACT) 的反应和毒性的免疫决定因素的前瞻性试验
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Cristina CASTILLA LLORENTE, MD
- 电话号码：+33 (0)1 42 11 42 39
- 邮箱：cristina.castilla-llorente@gustaveroussy.fr
研究联系人备份
- 姓名：Camille BIGENWALD, MD
- 电话号码：+33 (0)1 42 11 42 29
- 邮箱：camille.bigenwald@gustaveroussy.fr
学习地点
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Val de Marne
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Villejuif、Val de Marne、法国、94805
- 招聘中
- Gustave Roussy Cancer Campus Grand Paris
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接触：
- Camille BIGENWALD, MD
- 电话号码：+33 (0)1 42 11 42 29
- 邮箱：camille.bigenwald@gustaveroussy.fr
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接触：
- Clementine MAHAUT
- 电话号码：+33 (0)1 42 11 23 34
- 邮箱：clementine.mahaut@gustaveroussy.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：接受先进治疗药品的患者
|
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse 7 blood samples (25ml) will be taken: at day-7 before treatment start, at day0, at day+3, day+7, day+15, month+3 and at relapse If a bone marrow biopsy or aspiration is performed as part of routine care, 1 mL of bone marrow aspiration or one more biopsy will be sampled |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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使用光谱流式细胞术和 RNA 测序比较过继细胞治疗输注后肿瘤中不同免疫亚群的频率、表型和转录谱
大体时间：ACT 后 3 个月
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ACT 后 3 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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根据 CTCAE v5.0 分级的活检程序安全性（适用时）
大体时间：从注册到最后一个样本后 30 天
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从注册到最后一个样本后 30 天
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|
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Objective Response
大体时间：3 months following ACT
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Defined by RECIST 1.1 score for lymphoma and solid tumors |
3 months following ACT
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Progression-free survival
大体时间：5 years after first ACT infusion
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Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first. |
5 years after first ACT infusion
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Overall survival
大体时间：5 years after first ACT infusion
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Defined as the time between the adoptive cell therapy injection and death whatever the cause |
5 years after first ACT infusion
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.