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

Recruiting

• Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome

• Registration Number: NCT05643092
• Lead Sponsor: zhang shoulong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-05
• Study Start: 2023-03-06
• Last Update Posted: 2023-03-07
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
MRI scans for ICANS	up to 1 years post CAR T-cell infusion	Lesion location associated with severity of ICANS
To identify biomarkers for ICANS	up to 1 years post CAR T-cell infusion	Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)

Trial Locations

Locations (1)

980th Hospital; 🇨🇳 Shijia Zhuang, Hebei, China