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阿基仑赛注射液 CD19 CAR-T 细胞疗法在 10 例难治性大 B 细胞淋巴瘤患者中导致了高比例的全身性和神经系统缓解,包括 2 例 HIV 和病毒性肝炎患者。

Axicabtagene ciloleucel CD19 CAR-T cell therapy results in high rates of systemic and neurologic remissions in ten patients with refractory large B cell lymphoma including two with HIV and viral hepatitis.

机构信息

Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY, USA.

Department of Pharmacy, Montefiore Medical Center, The Bronx, NY, USA.

出版信息

J Hematol Oncol. 2020 Jan 3;13(1):1. doi: 10.1186/s13045-019-0838-y.

Abstract

Axicabtagene ciloleucel (Axi-cel) is a CD-19 Chimeric Antigen Receptor T cell therapy approved for the treatment of relapsed/refractory diffuse large B cell lymphoma. We treated ten patients with DLBCL post-FDA approval in an inner-city tertiary center in the Bronx. Eight patients (80%) had received ≥ 3 lines of therapy, six patients had received prior radiation, and seven had recurrent disease after prior autologous hematopoietic stem cell transplant (AHCT). Our cohort included one patient with HIV, two patients with hepatitis B, and two patients with CNS involvement of lymphoma. Axi-cel treatment led to significant responses with 8/10 patients achieving a complete remission at 3 months, including both patients with prior CNS involvement. The treatment was generally well tolerated with 20% of patients experiencing grade ≥ 2 CRS. One patient each with HIV and hepatitis B responded without significant toxicities. In conclusion, Axi-cel led to significant efficacy with manageable toxicity in DLBCL in a real-world setting.

摘要

阿基仑赛(Axicabtagene ciloleucel,Axi-cel)是一种 CD-19 嵌合抗原受体 T 细胞疗法,已获批准用于治疗复发/难治性弥漫性大 B 细胞淋巴瘤。在布朗克斯的一家市区三级中心,我们在 FDA 批准后治疗了 10 例 DLBCL 患者。8 例患者(80%)接受了≥3 线治疗,6 例患者接受了放疗,7 例患者在接受自体造血干细胞移植(AHCT)后复发。我们的队列包括 1 例 HIV 患者、2 例乙型肝炎患者和 2 例淋巴瘤中枢神经系统受累患者。Axi-cel 治疗导致了显著的反应,10 例患者中有 8 例在 3 个月时达到完全缓解,包括 2 例有中枢神经系统受累的患者。该治疗总体上耐受性良好,20%的患者出现≥2 级细胞因子释放综合征(CRS)。1 例 HIV 患者和 1 例乙型肝炎患者在无明显毒性的情况下出现应答。总之,在真实世界环境中,Axi-cel 在 DLBCL 中具有显著疗效且毒性可管理。

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