Evaluating Immunological Parameters, Neurocognitive Changes, Activity Levels, and Driving Fitness in Hematological Malignancy Patients Undergoing Chimeric Antigen Receptor (CAR)-T Cell Therapy

Study specific aims are: (1A) Evaluate changes in serum inflammatory cytokine protein markers in patients receiving CAR T-cell therapy; (1B) Evaluate changes in electroencephalographic and radiologic markers of CAR-T-related toxicities in comparison to neurocognitive function following CAR T-cell therapy; (2A) Assess changes in activity levels using actigraphy/accelerometry to continuously monitor physical activity; and (2B) Assess changes in driving performance using a standardized on-road instrumented vehicle drive.

Patients (n=20) will be recruited into the study if they are diagnosed with relapsed or refractory DLBCL or ALL, and scheduled to undergo commercially-available CAR T-cell therapy.

The following measures will be completed during primary study visits: prior to apheresis (T0) and 8-weeks post CAR-T cell infusion (T6). (1) blood inflammatory proteins; (2) brain wave recordings (or EEG), brain imaging, and neurocognitive assessment; (3) free-living activity levels; and (4) driving performance and safety. EEG will assess neural activity patterns of brain dysfunction; brain imaging will look for brain abnormalities; neurocognitive assessments will evaluate changes in thinking, concentration, and memory. A research-grade activity monitor will be used to assess activity levels. Driving performance and safety will be evaluated using a driving simulator and an on-road vehicle designed to monitor behavior while drivers complete a driving course. Analyses will assess changes between study visits, as well as relationships between immunological, neurological, activity, and driving measures.