Recruiting

CAR T-Cell Therapy

Sponsor:

UCLA

Code:

NCT07075523

Conditions

CAR T-Cell Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07075523

Start date

Sep 19, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Chimeric antigen receptor T-cell therapy

Patients recommended to undergo commercial CAR T-cell therapy

Interventions

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kathryn Tringale, MD, MAS

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

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Kathryn Tringale, MD, MAS

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

Krisma Montalvo

(858) 822-5354CancerCTO@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 13, 2026

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-07-13.