肿瘤细胞治疗研究
英文原题：A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
这是一项分期未标注的注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、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 20 例。试验地点：美国 · 巴斯金里奇、米德尔敦、蒙特维尔、科马克（共 8 个中心）。登记号：NCT07249528。
不限性别 · ≥ 18 Years
纳入标准：有病理确诊非霍奇金淋巴瘤或多发性骨髓瘤的记录；计划接受FDA批准的CAR-T产品：axi-cel、liso-cel、tisa-cel、ide-cel、cilta-cel或brexu-cel；研究者判断能够配合每日两次语音录音或每日神经系统评估；年龄≥18岁；ECOG≤2分；能够使用智能手机每日两次录音并接受每日神经系统评估（如ICE评分、震颤评估），且拥有智能手机；具备足够英语水平以完成研究应用中的结构化语音任务（应用及其声学模型目前仅经英语验证）；无显著影响言语的既往神经系统疾病（包括严重构音障碍、表达性失语或神经退行性疾病）；无显著言语或声音障碍史（包括喉麻痹、严重发声障碍、近期声带手术或该部位放疗）；无可能干扰语音分析的声带病变（如声带麻痹、慢性喉炎、声带结节、息肉、肉芽肿或恶性肿瘤）；无严重听力损害以致影响语音评估。要求能够说英语，无须达到母语水平；无法可靠完成任务或影响数据解释的语言障碍者排除。
Inclusion Criteria: * Documentation of Disease o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma. * Definition of treatment and ability * Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel. * Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator. * Age ≥ 18 * ECOG Performance Status of ≤ 2 * Required * Perform twice daily voice recordings using a smartphone. * Undergo daily neurologic assessments (e.g., ICE score, tremor evaluation). * Smartphone ownership. * Sufficient English proficiency to complete structured voice tasks in the study application. * Comorbid Conditions * No pre-existing neurological conditions that significantly impair speech, including but not limited to severe dysarthria, expressive aphasia, or neurodegenerative disorders. * No history of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation to the area. * No pathology affecting the vocal cords that could interfere with voice analysis, such as vocal cord paralysis, chronic laryngitis, vocal cord nodules, polyps, granulomas, or malignancies. * No severe hearing impairment that would interfere with voice assessments * Language o Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliabletask completion or data interpretation will be excluded.
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：Number of daily voice recordings collected · To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy. · 30 days after baseline；Number of neurocognitive assessments collected · To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy. · 30 days after baseline
参与者须经病理确诊为非霍奇金淋巴瘤或多发性骨髓瘤。
本研究收集接受标准CAR-T细胞治疗的非霍奇金淋巴瘤（NHL）或多发性骨髓瘤（MM）患者的语音录音和神经系统评估。研究者将考察这些录音和评估能否作为监测免疫效应细胞相关神经毒性综合征（ICANS）的可行方法。可行性将通过记录入组人数以及完成评估的人数衡量。
The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.
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