Brain scans and blood tests to spot neurotoxicity after CAR T-cell therapy
Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy
This project will try brain MRIs, cognitive tests, and blood biomarkers to see if we can identify which adults receiving CAR T-cell therapy will develop neurotoxicity (ICANS).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07075523 on ClinicalTrials.gov |
What this trial studies
This prospective, open-label, single-arm study enrolls adults scheduled for commercial CAR T-cell therapy and performs advanced brain MRI, neurocognitive testing, quality-of-life questionnaires, and blood biomarker measurements. Three MRI modalities (T1-post-contrast, T2/FLAIR, diffusion-weighted) plus resting-state functional MRI are used to capture structural and functional changes. Neurocognitive testing and questionnaires (including measures like RBANS) and blood — and optionally CSF — biomarker sampling are collected in the acute phase (2–14 days after infusion) and again at about 3 months. Data will be combined to develop a novel tool aimed at early identification of immune effector cell-associated neurotoxicity syndrome (ICANS).
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled to receive commercial CAR T-cell therapy and can comply with MRI and follow-up visits are ideal candidates.
Not a fit: Patients who are not receiving CAR T-cell therapy or who have contraindications to MRI (or severe pre-existing neurologic conditions that confound assessment) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the tool could identify patients at risk for ICANS earlier, allowing clinicians to intervene sooner and potentially reduce neurological complications.
How similar studies have performed: Smaller imaging and biomarker studies have shown promising signals for detecting ICANS, but a validated early predictive tool has not yet been established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn Tringale, MD, MAS — University of California, San Diego
- Study coordinator: Kathryn Tringale, MD, MAS
- Email: cancerCTO@health.ucsd.edu
- Phone: (858) 822-5354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.