Understanding Neurotoxicity After CAR T-Cell Therapy

This study aims to understand why some people experience neurotoxicity (problems with the brain and nervous system) after receiving chimeric antigen receptor (CAR) T-cell therapy for cancer. Researchers want to develop a new tool to identify early those patients who might develop immune effector cell-associated neurotoxicity syndrome (ICANS). If you are 18 or older, have signed an informed consent form, and are scheduled to receive commercial CAR T-cell therapy, you may be eligible. The study will involve brain magnetic resonance imaging (MRI), tests of your thinking and memory, quality of life questionnaires, and blood tests. The main goal is to see if a new tool can be developed to identify patients at risk for ICANS, with initial measurements taken at 2 weeks.

Study design
This is an observational study with 36 planned participants. It is a single-arm study, meaning all participants will receive the same evaluations.
What's involved
You would undergo brain MRI, neurocognitive assessments (tests of thinking and memory), and complete quality of life questionnaires. Blood samples will also be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 2 weeks, but the overall duration of follow-up is not specified.

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NCT07075523

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

Recruiting
Not specifiedAges 18+Observational
University of California, San Diego
~36 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Principal component analysis (PCA)
Measured over 2 weeks
CAR T-Cell Therapy
1 sites across 1 states
California1
  • Kathryn Tringale, MD, MAS · PRINCIPAL_INVESTIGATOR · University of California, San Diego

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Eligibility criteria

Inclusion

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

Contraindication for magnetic resonance imaging
  • Principal component analysis (PCA)2 weeks

    To identify relevant variables within three main domains (tumor imaging, neurocognitive assessments, and liquid biomarkers) collected acutely after chimeric antigen receptor (CAR) T-cell therapy that reflect distinct signatures associated with the presence of immune effector cell-associated neurotoxicity syndrome (ICANS).