肿瘤细胞治疗研究
英文原题：Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
⚠ 该试验的登记信息已有 21 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项分期未标注的注册临床试验，评估细胞治疗用于相关疾病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 100 例。试验地点：欧洲 · 博洛尼亚（共 1 个中心）。登记号：NCT06554951。
不限性别 · ≥ 18 Years 且 ≤ 90 Years
纳入标准： • 患有血液系统恶性肿瘤（复发/难治性 B 细胞淋巴瘤、B 细胞急性白血病或多发性骨髓瘤），正在接受或计划接受 CAR-T 细胞输注。 • 年龄≥18岁。 • 已签署参加研究的书面知情同意书。 排除标准：无。
Inclusion Criteria: * patients affeccted by any hematological malignancies (r/r B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product; * age: 18 years or greater; * obtained written consent to the study participation. Exclusion Criteria: * none
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。
主要终点：Response rate to treatment with CAR-T cells · For lymphoma: complete remission is defined by the absence of signs, symptoms, and PET/CT of the disease as described by Mac Manus MP et al. Cancer Imaging. 2007;7:10-8 For multiple myeloma: complete remission is defined as absence of M protein signs using standard tests, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates (Fernandez de Larrea C et al. Biol Blood Marrow Transplant. 2011 Jul;17:1084-7). For acute leukemia: complete remission is defined with less than 5% blasts in os-seo marrow and all other blood cell counts have returned to normal levels.Dohner H et al Blood. 2022;140:1345-1377. · 18 months
复发/难治性血液系统恶性肿瘤患者可能从 CAR-T 等创新疗法中获益，但目前尚不清楚哪些因素能可靠预测结局和治疗反应。细胞外囊泡（EV）参与细胞间通讯，并保留其来源细胞的特征；目前正被研究作为组织内生物学现象的候选生物标志物。初步数据提示，EV 可能预测治疗结局和毒性。因此，本研究旨在识别 CAR-T 细胞输注后与神经系统毒性相关的潜在 CAR-EV 生物标志物。
Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested. Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.
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