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多发性骨髓瘤中的CAR-T免疫监测(CART I5M)

英文原题:CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)

ClinicalTrials.gov 2026/01/15(首次登记) 注册临床试验(分期未标注) · 招募中

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于多发性骨髓瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 60 例。试验地点:欧洲 · 普瓦捷(共 1 个中心)。登记号:NCT07342179。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:年龄≥18岁;符合国际建议诊断标准的多发性骨髓瘤患者;按法国相关规定及授权即将接受CAR-T细胞治疗。排除标准:研究者认为严重的身心健康损害可能影响受试者遵从研究要求;同时参加仍处于排除期的其他研究;依法或行政决定被限制人身自由者、未成年人、妊娠或哺乳期女性、居住在医疗或社会照护机构者、受法律监护的成年人,以及急诊患者。
核对登记原文(英文)
Inclusion Criteria:

* Patient aged 18 and over
* Patient with Multiple Myeloma according to international recommendations,
* Patient about to receive CAR-T cell therapy in accordance with the rules and authorizations in France.

Exclusion Criteria:

* Patients with severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
* Simultaneous participation in another study with an ongoing exclusion period.
* Individuals receiving enhanced protection, namely minors, pregnant and/or breastfeeding women, individuals deprived of their liberty by a judicial or administrative decision, individuals residing in a healthcare or social care facility, adults under legal guardianship, and finally, patients in emergency situations

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点外周血CD3+ T细胞中TCF-1转录因子表达水平(MFI)最长1年。
  • 主要终点TCF-1转录因子表达水平与患者缓解深度的相关性最长1年。
  • 次要终点干性与CAR-BCMA淋巴细胞持续性的相关性,以及治疗后3个月和12个月骨髓中的细胞情况
  • 次要终点外周血膜CD95表达
  • 次要终点患者炎症特征
核对登记原文(英文)

主要终点:TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells · TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells at baseline and correlation with the percentage of CAR-BCMA+ T cells at different follow-up time points up to 1 year after CAR-BCMA treatment · up to 1 year;TCF-1 transcription factor (MFI) expression level in correlation with the depth of the patient's response as defined by international guidelines (IMS/IMWG criteria) · TCF-1 transcription factor (MFI) expression level in correlation with the depth of the patient's response as defined by international guidelines (IMS/IMWG criteria) · Up to 1 year
次要终点:Stemness correlation with the persistence of CAR-BCMA lymphocytes and in the bone marrow at 3 months and 12 months after CAR-BCMA treatment;Expression of membrane CD95 in peripheral blood;Inflammatory profile of patients

研究设计怎么做的

研究类型
干预性研究
入组人数
60 人(预计)
分组方式
不适用(单臂)
  • 1实验性
核对分组登记原文(英文)
  • 1 · EXPERIMENTAL

关键日期

开始日期
2026-02-13
主要完成日期
2032-10-03
全部完成日期
2032-10-03
登记状态核实于
2026-02

联系与责任方

申办方
Poitiers University Hospital
联系邮箱
arthur.bobin@chu-poitiers.fr
联系电话
0033549444201

登记简述

多发性骨髓瘤患者可接受细胞治疗,该疗法使用患者自身经改造的白细胞(T淋巴细胞)靶向骨髓瘤浆细胞表面的B细胞成熟抗原(BCMA)。这些改造后的T淋巴细胞称为CAR-T细胞(嵌合抗原受体T细胞)。改造淋巴细胞(CAR-BCMA)的长期持续存在,是疗效良好的公认指标。本研究拟分析与CAR-BCMA细胞持续存在相关的标志物。研究将与普瓦捷大学移植缺血再灌注、代谢和无菌性炎症实验室(IRMETIST,INSERM U1313)合作开展。项目将通过识别可预测抗癌治疗和/或免疫治疗有效应答的免疫细胞标志物,促进肿瘤患者照护。

核对登记原文(英文)

Multiple myeloma patients can be treated with cell therapy, which uses some of their own modified white blood cells (T lymphocytes) to target a protein (BCMA, or B-cell maturation antigen) found on the surface of the myeloma plasma cells. These modified T lymphocytes are called CAR T cells (chimeric antigen receptor T cells). The long-term persistence of these modified lymphocytes, or CAR-BCMA, is a recognized indicator of a good response to treatment. This research aims to study certain markers related to CAR-BCMA cell persistence. This research will be carried out in collaboration with the Laboratory of Ischemia Reperfusion, Metabolism and Sterile Inflammation in Transplantation (IRMETIST) INSERM unit U1313, located at the University of Poitiers. The proposed project will contribute to better patient care in the field of oncology, by identifying immunological cellular markers predictive of an effective response to anti-cancer treatments and/or immunotherapeutic targeting.

登记原文与核验信息

试验登记号
NCT07342179
试验期别
NA
试验状态
招募中
试验中心
Chu de Poitiers · 普瓦捷 · 法国
适应症(原文)
Multiple Myeloma (MM)
干预方式(原文)
Additional Bone Marrow cells and blood sampling