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Article Abstract
Phase I trials of chimeric antigen receptor (CAR) T cells have shown remarkable promise in pediatric B-cell malignancies. Such outcomes have shifted expectations for other phase I CAR T-cell trials to have high response rates. The juxtaposition of high expectations, uncertain outcomes, and potential for life-threatening toxicities raises unique ethical considerations. To aid patients and providers considering early-phase CAR T-cell trials, we discuss: (i) considerations for enrollment of pediatric patients, (ii) understanding trial intent and expectations, (iii) weighing risks and benefits, (iv) considerations for informed consent discussions, (v) post CAR T-cell therapy expectations, (vi) barriers to access, and (vii) vulnerability in decision making.
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| http://dx.doi.org/10.1002/pbc.31802 | DOI Listing |
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