Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of CAR-T-associated Neurotoxicity
研究概览
简要总结
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.
To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be ≥ 18 years of age at signing of informed consent.
- •Subjects are scheduled to receive CAR T-cell treatment.
排除标准
- •Refusal to sign the informed consent
- •Subjects having previously been treated with CAR-T therapy.
- •Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
- •Subjects presenting primary CNS lymphoma
- •Pacemaker or other implanted electrical device incompatible with the MR environment
- •Subjects with a neurodegenerative disease (PD, AD)
- •Subjects with a previous or evolving neurological pathology
- •Pregnant or breastfeeding women
结局指标
主要结局
Incidence of CAR-T-associated Neurotoxicity
时间窗: up to 3 years post CAR T-cell infusion
The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT
次要结局
- MRI scans for ICANS(up to 1 years post CAR T-cell infusion)
- To identify biomarkers for ICANS(up to 1 years post CAR T-cell infusion)
研究者
zhang shoulong
Principal Investigator
Hebei Medical University