Abstract
Chimeric antigen receptor (CAR) T-cells have shown remarkable promise in
children, adolescents and young adults with B-cell malignancies. Such
outcomes have shifted expectations for all phase I CAR T-cell trials to
be equally successful. The juxtaposition of high expectations, uncertain
outcomes, and potential for life-threatening toxicities raises unique
ethical challenges. To aid patients and providers considering enrollment
on early phase CAR T-cell trials, we discuss: (1) considerations for
enrollment of pediatric patients, (2) understanding trial intent and
expectations, (3) weighing risks and benefits, (4) considerations for
informed consent discussions, (5) post CAR T-cell therapy expectations,
and (6) barriers to access.