Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therap
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 syndro
| Condition(s) | CAR T-Cell Therapy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 follo |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of California, San Diego |
| Locations | La Jolla, California, United States |
| Start date | 2025-09-19 |
| NCT ID | NCT07075523 |
| Official listing | https://clinicaltrials.gov/study/NCT07075523 |