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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07075523
Status
Recruiting
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Conditions

  • CAR T-Cell Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers — OTHER
    Pathognomonic magnetic resonance imaging; neurocognitive assessments with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); quality of life assessment with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30; measurement of liquid biomarkers.

Study Details

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 Dates

Start date
Sep 19, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Chimeric antigen receptor T-cell therapy
    Patients recommended to undergo commercial CAR T-cell therapy

Primary Outcome Measure

Principal component analysis (PCA) [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Kathryn Tringale, MD, MAS
[email protected]
(858) 822-5354
Krisma Montalvo
[email protected]
(858) 822-5354

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