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

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 Overview

• Status: Recruiting
• Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijia Zhuang, Hebei, China
      • Recruiting
      • 980th Hospital
      • Contact: Shoulong Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study using a consecutive patient sample.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CAR-T-associated Neurotoxicity	The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT	up to 3 years post CAR T-cell infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: zhang shoulong
• Collaborators: Changhai Hospital; Jinan Military General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Disease; Poisoning; Syndrome; Neurotoxicity Syndromes
• Other Study ID Numbers: 168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No