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我如何处理儿科 I 期 CAR-T 细胞试验的伦理考量

英文原题:How I Approach Ethical Considerations for Pediatric Phase I CAR T-Cell Trials.

查看英文原题

How I Approach Ethical Considerations for Pediatric Phase I CAR T-Cell Trials.

PubMed 2025/05/28(内容时间) Pediatr Blood Cancer Q2 · IF 2.4(JCR 2025)

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中文摘要

嵌合抗原受体(CAR)T细胞I期试验在儿童B细胞恶性肿瘤中显示出显著前景。这些结果使人们对其他CAR-T 细胞I期试验的高缓解率也产生了较高期待。高期待、不确定结局及潜在危及生命的毒性并存,带来了独特伦理考量。为帮助患者及医务人员考虑是否参加早期CAR-T 细胞试验,我们讨论:(i)儿童患者入组相关考量;(ii)理解试验目的和预期;(iii)权衡风险与获益;(iv)知情同意讨论事项;(v)CAR-T 细胞治疗后的预期;(vi)治疗可及性障碍;以及(vii)决策中的脆弱性。

展开英文摘要原文

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.

论文信息

作者
Peters SW、Silbert SK、Holland EM、Rid A、Rouce RH、Grady C、Shah NN
单位
Pediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, Maryland, USA.United States
期刊
Pediatric blood & cancer2025 Aug
原文标识
PubMed 40437658 · DOI 10.1002/pbc.31802