NCT07075523 Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy
| NCT ID | NCT07075523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | CAR T-Cell Therapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-09-19 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kathryn Tringale, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT07075523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CAR T-Cell Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07075523 currently recruiting?
Yes, NCT07075523 is actively recruiting participants. Contact the research team at cancerCTO@health.ucsd.edu for enrollment information.
Where is the NCT07075523 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07075523 clinical trial?
NCT07075523 is sponsored by University of California, San Diego. The principal investigator is Kathryn Tringale, MD, MAS at University of California, San Diego. The trial plans to enroll 36 participants.