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

NCT07075523 | Recruiting DMC

• 1 other identifier: 811868
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAR T-Cell Therapy

Keywords

CAR T-cell therapy; RBANS; ICANS; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Principal component analysis (PCA)

  To identify relevant variables within three main domains (tumor imaging, neurocognitive assessments, and liquid biomarkers) collected acutely after chimeric antigen receptor (CAR) T-cell therapy that reflect distinct signatures associated with the presence of immune effector cell-associated neurotoxicity syndrome (ICANS).

  2 weeks

Study Arms (1)

Chimeric antigen receptor T-cell therapy

Patients recommended to undergo commercial CAR T-cell therapy

Other: Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers

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.

Chimeric antigen receptor T-cell therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

see eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• Contraindication for magnetic resonance imaging

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Biomarkers

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Kathryn Tringale, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Tringale, MD, MAS

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)