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

Sponsor

zhang shoulong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05643092

Collaborator

Jinan Military General Hospital (Other), Changhai Hospital (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Effector Cell Associated Neurotoxicity Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

zhang shoulong
Jinan Military General Hospital
Changhai Hospital

Investigators

Principal Investigator: Shoulong Zhang, 980th Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

zhang shoulong, Principal Investigator, Hebei Medical University

ClinicalTrials.gov Identifier:

NCT05643092

Other Study ID Numbers:

First Posted:

Dec 8, 2022

Last Update Posted:

Dec 8, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neurotoxicity Syndromes

Syndrome

Study Results

No Results Posted as of Dec 8, 2022