肿瘤细胞治疗研究
英文原题：Neurocognitive Trajectories After BCMA CAR-T
Neurocognitive Trajectories After BCMA CAR-T
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
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：尚未开始招募。计划入组 50 例。试验地点：美国 · 夏洛特（共 1 个中心）。登记号：NCT07740317。
不限性别 · ≥ 18 Years
纳入标准：能够理解并愿意签署经IRB批准的知情同意书；经入组研究者判断，能够保持独立决策能力；签署同意时年龄≥18岁；经主治临床医生确认，计划接受BCMA CAR-T 治疗复发/难治性多发性骨髓瘤；能够阅读并理解英语；ECOG体能状态0-2分；若正在使用苯二氮䓬类药物，须能按主治医生要求在研究评估前停药3小时；可稳定使用互联网以及带摄像头的平板、笔记本或台式电脑，或愿意按研究日程到诊所完成研究程序（依据受试者自述）；经主治临床医生判断能够完成所需评估。排除标准：活动性中枢神经系统疾病；已知神经退行性疾病或重度神经认知障碍；过去12个月内发生卒中和/或创伤性脑损伤；同时使用研究性神经活性药物。
Inclusion Criteria: 1. Ability to understand and willingness to sign an IRB-approved informed consent 2. Ability to retain independent decision-making capacity as per the enrolling investigator 3. Age ≥ 18 years of age at the time of consent 4. Scheduled to receive BCMA CAR-T therapy for RRMM as confirmed by the treating clinician 5. Ability to read and understand the English language 6. ECOG 0-2 7. If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician 8. Reliable access to internet access; a tablet, laptop and/or desktop computer with a camera; or willingness to come into the clinic to conduct study procedures as outlined in the Study Calendar- as per participant self-report 9. Ability to complete required assessments, as determined by the treating clinician Exclusion Criteria: 1. Active central nervous system (CNS) disease 2. Known neurodegenerative disease or major neurocognitive disorder 3. Stroke and/or traumatic brain injury (TBI) within 12 months 4. Concurrent investigational neuroactive drugs
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：Clinically significant cognitive impairment · For each timepoint in which the Cognitive Assessment Battery is assessed (baseline, 1-, 6-, and 12 months post-CAR-T), the overall clinically significant impairment will be determined as a binary variable. Clinically significant impairment will be determined if 2 individual cognitive tests (from ICCTF or Digit Span subtest) have a standardized score at least 1.5 standard deviations below the mean or if 1 individual cognitive test has a standardized score at least 2 standard deviations below the mean. · Baseline, 1-, 6-, and 12-months post-CAR-T
次要终点：Hopkins Verbal Learning Test - Revised (HVLT-R) total recall score；Hopkins Verbal Learning Test - Revised (HVLT-R) retention score %；Hopkins Verbal Learning Test - Revised (HVLT-R) Recognition Discrimination Index (RDI)；Oral Trail-Making Test Part A (OTMT-A) results, seconds；Oral Trail-Making Test Part B (OTMT-B) results, seconds；Controlled Oral Word Association Test (COWAT) results；Wechsler Adult Intelligence Scale (WAIS)-III Digit Span subtest results；Number of participants who completed the study
接受标准治疗商业化BCMA CAR-T 治疗的复发/难治性多发性骨髓瘤患者。
以上邮箱 / 电话是登记库里的申办方联系方式，通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
本研究旨在评估复发/难治性多发性骨髓瘤患者接受CAR-T 细胞治疗后的认知变化及其随时间的轨迹。
The purpose of this research study is to evaluate cognitive changes over time in participants with relapsed or refractory multiple myeloma who have received chimeric antigen receptor T-cell therapy (CAR-T).
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