CAR-T（CAR-T）细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T（CAR-T）细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
推进 CAR-T 细胞治疗：肿瘤学中 CAR-T 细胞治疗的循证试验设计
英文原题：Advancing CAR T-Cell Therapy: Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology.
查看英文原题
Advancing CAR T-Cell Therapy: Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology.
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中文摘要
本观点文章讨论了美国食品药品监督管理局最近决定取消用于治疗癌症的嵌合抗原受体（CAR）T细胞疗法的风险评估与减轻策略要求。
展开英文摘要原文
This Viewpoint discusses the recent decision by the US Food and Drug Administration to eliminate Risk Evaluation and Mitigation Strategies requirements for chimeric antigen receptor (CAR) T-cell therapies for the treatment of cancer.
论文信息
- 作者
- Mahat U、Das A、Kumar V、Prasad V
- 第一作者单位
- Division of Clinical Evaluation Hematology, Office of Clinical Evaluation, Center for Biologic Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
- 通讯作者单位
- Center for Biologic Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
- 期刊
- JAMA2026 Jan 6
- 原文标识
- PubMed 41359310 · DOI 10.1001/jama.2025.21721