决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
英文原题:Assessing DCog Short for Neurotoxicity in CAR-T
Assessing DCog Short for Neurotoxicity in 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,评估细胞治疗用于血液系统恶性肿瘤、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 40 例。试验地点:美国 · 波士顿(共 1 个中心)。登记号:NCT07403812。
不限性别 · ≥ 18 Years
纳入标准:接受CAR-T 细胞治疗且有治疗相关神经毒性风险;视力达到20/100或更好。 排除标准:未满18岁;妊娠;囚犯;无法提供知情同意的成年人;不愿使用iPad工具者;严重运动障碍导致无法使用iPad者。
Inclusion Criteria: * participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity. * Visual acuity of 20/100 or better. Exclusion Criteria: * patients \< 18 years old * pregnant women * prisoners * adults unable to consent, * participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad
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:Sensitivity of DCog Short for Early Detection of Neurotoxicity · Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to detect neurotoxicity on or before the onset of clinically confirmed ICANS. Sensitivity is defined as the proportion of patients with clinically confirmed ICANS for whom DCog Short indicates neurotoxicity on or before ICANS onset. DCog Short will be considered effective if sensitivity is ≥75% and non-promising if sensitivity is \<50%. · Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.;Specificity of DCog Short for Early Detection of Neurotoxicity · Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Specificity is defined as the proportion of patients who do not develop clinically confirmed ICANS and are not indicated by DCog Short. DCog Short will be considered effective if specificity is ≥75% and non-promising if specificity is \<50%. · Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.;Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity · Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Positive predictive value is defined as the proportion of patients indicated by DCog Short who subsequently develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment. · Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.;Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity · Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Negative predictive value is defined as the proportion of patients not indicated by DCog Short who do not develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment. · Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.;Raw Accuracy of DCog Short for Early Detection of Neurotoxicity · Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Raw accuracy is defined as the proportion of patients correctly classified by DCog Short, including both patients who develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and those who do not, based on standard clinical assessment. · Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.
次要终点:Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline;Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types
40名参与者完成基线访视;住院期间每日访视,之后电话随访:第14–21天每周2次,第21–30天每周1次;第90天随访。
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。
本研究旨在确定自我报告式iPad应用工具DCog Short评估CAR-T 细胞治疗参与者神经毒性的效果。
The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.
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