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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05643092

Enrollment

Registered

2022-12-08

Start date

2023-03-06

Completion date

2027-12-31

Last updated

2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactShoulong Zhang

longer_human007@126.com86-0311-98224

Outcome results