Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05643092

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

980th Hospital

Shijiazhuang, Hebei, China

Location status: Recruiting

Location contact

Shoulong Zhang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of CAR-T-associated Neurotoxicity

    Time frame: up to 3 years post CAR T-cell infusion

    The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT

Secondary outcomes

  1. To identify biomarkers for ICANS

    Time frame: up to 1 years post CAR T-cell infusion

    Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)

  2. MRI scans for ICANS

    Time frame: up to 1 years post CAR T-cell infusion

    Lesion location associated with severity of ICANS

Study contacts

Contact information is provided by the study sponsor or research team.

Shoulong Zhang

CONTACT

[email protected]

86-0311-98224

Sponsors and collaborators

Lead sponsor

zhang shoulong

Other

Collaborators

  • Changhai Hospital
  • Jinan Military General Hospital

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.