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CAR-T 细胞给药的实践方面:从商业化到即时生产

英文原题:Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing.

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Practical aspects of chimeric antigen receptor T-cell administration: From commercial to point-of-care manufacturing.

PubMed 2022/09/27(内容时间) Front Immunol Q1 · IF 7(JCR 2025)

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中文摘要

靶向CD19抗原的CAR-T 细胞在复发/难治性(R/R)B细胞恶性肿瘤患者中取得了令人瞩目的结果,从而在欧洲联盟及其他司法管辖区获得批准。在西班牙,100%学术性抗CD19 CAR-T 细胞产品varnimcabtagene autoleucel(var-cel,ARI-0001细胞)已根据医院豁免条款获得特别批准,用于治疗25岁以上R/R急性淋巴细胞白血病患者。Var-cel也已就同一适应症获得欧洲药品管理局的优先药物资格认定。在这篇综述中,我们以var-cel为例,揭示与学术性即时检验CAR-T 细胞产品制备和给药相关的一些实践方面,并将其置于商业化产品的背景下进行讨论。

展开英文摘要原文

Chimeric antigen receptor T-cells targeting the CD19 antigen have achieved impressive results in patients with relapsed/refractory (R/R) B-cell malignancies, leading to their approval in the European Union and other jurisdictions. In Spain, the 100% academic anti-CD19 CART-cell product varnimcabtagene autoleucel (var-cel, ARI-0001 cells) has been extraordinarily approved under the Hospital Exemption clause for the treatment of patients older than 25 years of age with R/R acute lymphoblastic leukaemia.

Var-cel has also been granted PRIority MEdicines designation by the European Medicines Agency for the same indication. In this review we reveal some practical aspects related to the preparation and administration of academic point-of-care CART-cell products, using var-cel as an example, and put them into the context of commercial products.

论文信息

作者
Martinez-Cibrian N、Español-Rego M、Pascal M、Delgado J、Ortiz-Maldonado V
单位
Department of Haematology, Hospital Clínic de Barcelona, Barcelona, Spain.Spain
文献类型
综述
期刊
Frontiers in immunology2022
原文标识
PubMed 36238283 · DOI 10.3389/fimmu.2022.1005457