Home › NCT07075523
Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy
Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Contraindication for magnetic resonance imaging
About the study
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.
What is being tested
- Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers (other)
Sponsor: University of California, San Diego · Participants: 36 · Started: Sep 19, 2025
Contact the study team
- Kathryn Tringale, MD, MAS · Phone: (858) 822-5354
Official record on ClinicalTrials.gov — NCT07075523
Locations in the U.S.
| California | University of California, San Diego, La Jolla |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.