CAR-T（CAR-T）细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T（CAR-T）细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
床旁 CAR-T 细胞治疗作为不符合规格 tisagenlecleucel 的挽救策略
英文原题：Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel.
查看英文原题
Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel.
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中文摘要
Tisagenlecleucel（tisa-cel）是一种抗CD19嵌合抗原受体（CAR）T细胞疗法，获批用于复发/难治性大B细胞淋巴瘤患者。不符合商业规格（OOS）的CAR-T 细胞产品患者的结局尚未得到充分描述。
因此，我们评估了在单中心接受tisa-cel治疗白细胞采集的37例成人患者。在9例（24%）患者中，生产的tisa-cel被认为OOS。其中3例（33%）在机构审查委员会批准后接受了tisa-cel；2/9（22%）因疾病进展未接受tisa-cel；4/9（44%）在OOS通知后中位35天接受了学术性即时护理（POC）CAR-T 细胞作为挽救治疗。这4例患者中有3例达到完全缓解。在单变量分析中，OOS的危险因素为既往接受过4线治疗或既往暴露于bendamustine。
总之，我们报告了真实世界中高达24%的OOS发生率。这些患者中44%接受了POC CAR-T 细胞作为挽救治疗。
展开英文摘要原文
Tisagenlecleucel (tisa-cel) is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for patients with relapsed/refractory large B-cell lymphoma. Outcomes of patients with out-of-commercial specification (OOS) CAR T products are not well characterized.
We therefore assessed 37 adult patients who underwent leukapheresis for tisa-cel therapy in a single center. In nine (24%) patients, manufactured tisa-cel was considered OOS.
Three of them (33%) received tisa-cel after institutional review board approval; 2/9 (22%) did not receive tisa-cel due to disease progression; and 4/9 (44%) received academic point-of-care (POC) CAR T-cell as salvage therapy, at a median of 35 days following OOS notification. Three of those four patients achieved a complete response. In univariate analysis, risk factors for OOS were 4 prior therapies or previous bendamustine exposure.
In conclusion, we report high OOS incidence of 24% in real-life setting. Forty-four percent of those patients received POC CAR T-cell as salvage therapy.
论文信息
- 作者
- Fried S、Shouval R、Varda-Bloom N、Besser MJ、Yerushalmi R、Shem-Tov N、Danylesko I、Jacoby E
- 单位
- Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel Hashomer, Israel.Israel
- 期刊
- Leukemia & lymphoma2022 Dec
- 原文标识
- PubMed 36111694 · DOI 10.1080/10428194.2022.2123232