Cell expansion is typically a long and labor-intensive step in CAR-T cell manufacture. The Xuri Cell Expansion System (CES) W25 semiautomates this step while functionally closing the process. Cells for autologous or allogeneic cell therapies are cultured inside a single-use Xuri Cellbag ...
autologous; chimeric antigen receptor T cell; cell therapy products; CMC changes; production capacity; validation strategies; post-approval change management protocol 基金项目 2023 年中国药品监督管理研究会课题(2023-Y-Y-012) 自从首款...
autologous; chimeric antigen receptor T cell; cell therapy products; CMC changes; production capacity; validation strategies; post-approval change management protocol 自从首款嵌合抗原受体T 细胞(chimeric antigen receptor T cell,CAR-T cell)治疗产品被美国食品药品监督管理局(Food and Drug Administration,FDA)...
根据protocol,22例患者接受了LV20.19 CAR-T细胞治疗。 临床结果(来源:Nature Medicine) 在CAR-T细胞特异性毒性方面,64%的患者(n=14)出现了细胞因子释放综合征(CRS),其中5%(n=1)患者出现3-4级CRS。32%的患者(n=7)出现神经毒性,其中,14%的患者(n=3)为3-4级神经毒性。所有患者的神经系统全部恢复。有1例...
Notably, AUTO4 CAR T cells predominantly displayed an effector memory or terminally differentiated immunophenotype, potentially reflecting the 10-day expansion protocol used in the study. In diffuse large B cell lymphoma, a high area under the curve for CAR T cell detection over the first 28 days...
因此,大多数当前protocol的目标是生产主要具有中央记忆(CD62L高表达和CCR7高表达的CD45RO+)表型的CAR-T细胞,而不是效应记忆细胞(CD62L低表达和CCR7低表达的CD45RO+)表型(见图2),后者通常不利于迁移到肿瘤。下文详细讨论了解决CAR-T细胞误引导的方法。
CRISPR-Cas9-mediated gene editing can be exploited to ameliorate CAR T-cell dysfunction Numerous factors often collectively prevent durable remissions following CAR T-cell therapy, including autologous CAR T-cell manufacturing issues, limited CAR T-cell expansion and/or persistence as well as various ...
Cell expansion is typically a long and labor-intensive step in CAR-T cell manufacture. The Xuri Cell Expansion System (CES) W25 semiautomates this step while functionally closing the process. Cells for autologous or allogeneic cell therapies are cultured inside a single-use Xuri Cellbag bioreactor...
本届EBMT年会期间,来自意大利的Eugenio Galli教授团队报道了一项髓源性抑制细胞(MDSC)水平升高会导致 CAR-T 细胞扩增能力下降和疗效受损的研究结果(摘要号:OS6-02)。【肿瘤资讯】特作整理,以供学习。 摘要号:OS6-02 标题:ELEVATED ...
在各种癌症免疫治疗方法中,CAR-T疗法有些与众不同,它并不依赖于患者自身的免疫力。如果把PD-1等其它免疫疗法比作帮助患者“修炼内功”的话,CAR-T则相当于有人给患者“传功”。 但其实,“传功”也能帮助“修炼内功”。最近费城儿童医院的一...