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.
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
Contraindication for magnetic resonance imaging
see eligibility criteria
Cohort
Prospective
Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers
Other interventionPathognomonic 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.
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).
Click on the lead sponsor to view all of their trials.
