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

Recruiting now

Conditions studied: CAR T-Cell Therapy

In brief

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.

Key facts

Study ID

NCT07075523

Run by

University of California, San Diego

People needed

36

Starts

2025-09-19

Expected to finish

2027-12-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Contraindication for magnetic resonance imaging

Where it is running

• University of California, San Diego — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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