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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-06

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Immune Effector Cell Associated Neurotoxicity Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No