Brain scans and blood tests to spot neurotoxicity after CAR T-cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.