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CAR-T cell manufacturing failures and out-of-specification products in the real-world setting: A survey from the EBMT cellular therapy and immunobiology working party.

作者信息

Worel Nina, Mooyaart Jarl E, Hoogenboom Jorinde D, Daskalakis Michael, Tudesq Jean-Jacques, Ram Ron, Vucinic Vladan, Bramanti Stefania, Corral Lucía López, Nicholson Emma, Zeiser Robert, Stölzel Friedrich, Galli Eugenio, Pagliuca Simona, Wagner-Drouet Eva, Calkoen Friso, Chabannon Christian, Malard Florent, Ruggeri Annalisa, Kuball Jürgen

机构信息

Department of Transfusion Medicine and Cell Therapy, Medical University Vienna, Vienna, Austria.

EBMT Leiden Study Unit, Leiden, The Netherlands.

出版信息

Bone Marrow Transplant. 2025 May 15. doi: 10.1038/s41409-025-02623-0.

DOI:10.1038/s41409-025-02623-0
PMID:
40374897
Abstract
摘要

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引用本文的文献

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Impact of cellular composition and T-cell senescence of mononuclear cell concentrates on the manufacturing process of chimeric antigen receptor (CAR) T-cells.单核细胞浓缩物的细胞组成和T细胞衰老对嵌合抗原受体（CAR）T细胞制造过程的影响。
Transfusion. 2025 Sep;65(9):1650-1661. doi: 10.1111/trf.18354. Epub 2025 Jul 29.

本文引用的文献

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Blood. 2025 Jan 2;145(1):85-97. doi: 10.1182/blood.2024025945.
2
Real-life experiences with CAR T-cell therapy with idecabtagene vicleucel (ide-cel) for triple-class exposed relapsed/refractory multiple myeloma patients.接受 idecabtagene vicleucel（ide-cel）CAR-T 细胞疗法治疗三重暴露复发/难治性多发性骨髓瘤患者的真实临床经验。
BMC Cancer. 2023 Apr 15;23(1):345. doi: 10.1186/s12885-023-10824-3.
3
Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium.
伊达比星脂质体阿仑单抗治疗复发/难治性多发性骨髓瘤：多发性骨髓瘤嵌合抗原受体 T 细胞联盟的真实世界经验。
J Clin Oncol. 2023 Apr 10;41(11):2087-2097. doi: 10.1200/JCO.22.01365. Epub 2023 Jan 9.
4
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study.西达基奥仑赛，一种针对 B 细胞成熟抗原的嵌合抗原受体 T 细胞疗法，用于治疗复发或难治性多发性骨髓瘤患者（CARTITUDE-1）：一项 1b/2 期开放标签研究。
Lancet. 2021 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24.
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Blood Adv. 2020 Nov 10;4(21):5414-5424. doi: 10.1182/bloodadvances.2020003092.
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Lancet. 2020 Sep 19;396(10254):839-852. doi: 10.1016/S0140-6736(20)31366-0. Epub 2020 Sep 1.
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N Engl J Med. 2019 Jan 3;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.
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N Engl J Med. 2018 Feb 1;378(5):439-448. doi: 10.1056/NEJMoa1709866.
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Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma.阿基仑赛注射液嵌合抗原受体T细胞疗法治疗难治性大B细胞淋巴瘤
N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.