肿瘤细胞治疗研究
英文原题：Early Assessment of Cardiac Function After Treatment With CAR-T Cells
⚠ 该试验的登记信息已有 13 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，评估细胞治疗用于血液系统恶性肿瘤、急性淋巴细胞白血病、淋巴瘤的安全性、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 · 巴黎（共 1 个中心）。登记号：NCT06350994。
不限性别 · ≥ 18 Years
纳入标准： • 超声心动图检查前3–5天内已接受 CAR-T 细胞输注。 • 有治疗前心脏评估：按 Saint-Antoine 医院血液科现行建议和标准诊疗方案，在预处理及 CAR-T 输注前完成超声心动图和心电图。 • 不反对参加研究。 • 参加法国社会保障体系或享有国家医疗援助（AME）。 排除标准： • 反对参加或撤回同意。
Inclusion Criteria: * CAR-T cells infusion received within 3 to 5 days before the echocardiography * Pre-therapeutic cardiac assessment (in accordance with the recommendations and standard care protocol in force in the hematology department of Saint-Antoine Hospital): Echocardiography and EKG before conditioning and infusion of CAR -T cells, * Not opposed to participating in research. * Patient affiliated to a social security system or beneficiary of the "state medical insurance help" (namely aide médicale d'état). Exclusion Criteria: * Opposition or consent withdrawal
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：Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity · Transthoracic bedside echocardiographic evaluation of the LVEF. · 5 days and 3 months
次要终点：Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations；Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients
床旁经胸超声心动图检查。
CAR-T 细胞是一种基于自体 T 淋巴细胞基因改造的新型免疫疗法，也可能引起并发症。常见并发症包括感染、细胞因子释放综合征（CRS）和神经毒性。少数患者曾报告严重急性心脏事件，常与 CRS 或脓毒症同时发生，因此 CAR-T 对心脏的影响尚待明确。本研究旨在估算 CAR-T 细胞相关早期心脏毒性的发生率。主要终点为比较 CAR-T 治疗前和治疗后早期（第3–5天）超声心动图评估的左室射血分数（LVEF）变化。
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications. Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease. This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells. The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).
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