RecruitingNCT07075523

Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy

Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy


Sponsor

University of California, San Diego

Enrollment

36 participants

Start Date

Sep 19, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to understand why some people receiving chimeric antigen receptor (CAR) T-cell therapy for cancer experience neurotoxicity. The main question it aims to answer is: Can a novel tool be developed to identify early the patients who will develop immune effector cell-associated neurotoxicity syndrome (ICANS, also called neurotoxicity) after chimeric antigen receptor (CAR) T-cell therapy? Participants already scheduled for chimeric antigen receptor (CAR) T-cell therapy as part of the medical care for their cancer will be evaluated with advanced neuroimaging techniques. In addition, neurocognitive assessments using questionnaires and measurement of biomarkers in blood (liquid biomarkers) will be performed to provide a comprehensive characterization of neurotoxicity following chimeric antigen receptor T-cell therapy. Assessments will be performed in the acute phase (2 to 14 days after chimeric antigen receptor (CAR) T-cell therapy) and after approximately 3 months.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Provision of signed and dated informed consent form
  • Age ≥ 18 years
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Patients recommended to undergo commercial chimeric antigen receptor T-cell therapy

Exclusion Criteria1

  • Contraindication for magnetic resonance imaging

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Interventions

OTHERBrain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers

Pathognomonic magnetic resonance imaging; neurocognitive assessments with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); quality of life assessment with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30; measurement of liquid biomarkers.


Locations(1)

University of California, San Diego

La Jolla, California, United States

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NCT07075523


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