医学
挽救疗法
嵌合抗原受体
内科学
汽车T细胞治疗
细胞因子释放综合征
耐火材料(行星科学)
肿瘤科
外科
免疫疗法
癌症
化疗
天体生物学
物理
作者
Shalev Fried,Roni Shouval,Nira Varda‐Bloom,Michal J. Besser,Ronit Yerushalmi,Noga Shem‐Tov,Ivetta Danylesko,Elad Jacoby,Shlomit Teihman,Orit Itzhaki,Joshua Fein,Meirav Kedmi,Avichai Shimoni,Abraham Avigdor
标识
DOI:10.1080/10428194.2022.2123232
摘要
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.
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