Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

zhang shoulong50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must be ≥ 18 years of age at signing of informed consent. * Subjects are scheduled to receive CAR T-cell treatment. Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Incidence of CAR-T-associated Neurotoxicity

The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT

Time frame: up to 3 years post CAR T-cell infusion

Secondary Outcomes

To identify biomarkers for ICANS

Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)

Time frame: up to 1 years post CAR T-cell infusion

MRI scans for ICANS

Lesion location associated with severity of ICANS