Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Diego
RECRUITING
La Jolla
Contact Information
Primary
Kathryn Tringale, MD, MAS
cancerCTO@health.ucsd.edu
(858) 822-5354
Time Frame
Start Date: 2025-09-19
Estimated Completion Date: 2027-12
Participants
Target number of participants: 36
Treatments
Chimeric antigen receptor T-cell therapy
Patients recommended to undergo commercial CAR T-cell therapy
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov

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