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

NCT05643092 · tracked via the Priya Life Science China tracker

Sponsor

zhang shoulong

Phase

Observational

Started

2023-03-06

Last updated

2023-03-07

Condition(s) studied

Immune Effector Cell Associated Neurotoxicity Syndrome

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of CAR-T-associated Neurotoxicity — up to 3 years post CAR T-cell infusion
The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT

Trial sites (1)

Facility	City	Region	Status
980th Hospital	Shijiazhuang	Hebei	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05643092 on ClinicalTrials.gov ↗ ← All trials in China