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Talicabtagene Autoleucel:首次获批

英文原题:Talicabtagene Autoleucel: First Approval.

查看英文原题

Talicabtagene Autoleucel: First Approval.

PubMed 2024/05/23(内容时间) Mol Diagn Ther Q1 · IF 5.8(JCR 2025)

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中文摘要

Talicabtagene autoleucel(NexCAR19)是一种正在由印度理工学院孟买分校(IIT-B)和 Immunoadoptive Cell Therapy(ImmunoACT)开发的嵌合抗原受体(CAR)T 细胞疗法,用于治疗复发/难治性 B 细胞恶性肿瘤。该疗法采用患者自体 T 细胞,经改造表达靶向 B 细胞的人源化抗 CD19 CAR。在一项 I 期和一项 II 期试验汇总结果中,复发/难治性 B 细胞恶性肿瘤患者单次静脉给予 talicabtagene autoleucel 后缓解率较高。2023 年 10 月 13 日,印度批准该疗法用于复发/难治性 B 细胞淋巴瘤及复发/难治性 B 细胞急性淋巴细胞白血病。本文总结了 talicabtagene autoleucel 的研发里程碑,并介绍其首次获批用于上述疾病的历程。

展开英文摘要原文

Talicabtagene autoleucel (NexCAR19 ) is a chimeric antigen receptor (CAR) T-cell therapy being developed by the Indian Institute of Technology, Bombay (IIT-B) and Immunoadoptive Cell Therapy (ImmunoACT) for the treatment of relapsed/refractory B-cell malignancies. Talicabtagene autoleucel contains autologous T cells from the patient, which have been modified to express a humanized anti-CD19 CAR that targets B cells.

A single intravenous dose of talicabtagene autoleucel was associated with high response rates in pooled results from a phase I and phase II trial in patients with relapsed/refractory B-cell malignancies. Talicabtagene autoleucel was approved in India for the treatment of relapsed/refractory B-cell lymphomas and relapsed/refractory B-cell acute lymphoblastic leukaemia on 13 October 2023.

This article summarizes the milestones in the development of talicabtagene autoleucel leading to this first approval for relapsed/refractory B-cell lymphomas and relapsed/refractory B-cell acute lymphoblastic leukaemia.

论文信息

作者
Nie T
单位
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. mdt@adis.com.Iran
文献类型
综述
期刊
Molecular diagnosis & therapy2024 Jul
原文标识
PubMed 38780683 · DOI 10.1007/s40291-024-00719-9