肿瘤细胞治疗研究
英文原题：Obecabtagene Autoleucel: First Approval.
Obecabtagene Autoleucel: First Approval.
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
Obecabtagene autoleucel（AUCATZYL）是一种靶向 CD19 的基因修饰自体 T 细胞免疫疗法，由 Autolus 开发，用于治疗血液系统恶性肿瘤和系统性红斑狼疮。
Obecabtagene autoleucel（AUCATZYL）是一种靶向CD19的基因修饰自体T细胞免疫疗法，由Autolus开发，用于治疗血液系统恶性肿瘤和系统性红斑狼疮。与其他CAR-T（CAR-T）疗法相比，obecabtagene autoleucel具有对CD19的快速解离率结合子。Obecabtagene autoleucel在FELIX I/II期试验中于复发/难治性B细胞前体急性淋巴细胞白血病（ALL）成人患者中取得阳性结果后获得批准，并且是首个无需强制性风险评价与缓解策略监测要求的CAR-T 疗法。本文总结了obecabtagene autoleucel研发过程中的里程碑，直至其首次获批用于治疗复发/难治性B细胞前体ALL成人患者。
Obecabtagene autoleucel (AUCATZYL ) is a CD19-directed genetically modified autologous T cell immunotherapy which is being developed by Autolus for the treatment of hematological cancers and systemic lupus erythematosus. In comparison with other chimeric antigen receptor T (CAR T) therapies, obecabtagene autoleucel has a fast off-rate binder for CD19. Obecabtagene autoleucel received approval following positive results from the FELIX phase I/II trial in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and it is the first CAR T therapy that does not have mandatory Risk Evaluation Mitigation Strategy monitoring requirements. This article summarizes the milestones in the development of obecabtagene autoleucel leading to this first approval for the treatment of adults with relapsed or refractory B-cell precursor ALL.
MEMBER ACCOUNT
登录成功会直接打开下一页。
