Ma Yongyong, Zhang Shenghui, Fang Hongliang, Yu Kang, Jiang Songfu
Department of Hematology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, P.R. China.
R&D Department, Hrain Biotechnology Co. Ltd., Shanghai 200030, P.R. China.
Oncol Lett. 2020 Oct;20(4):20. doi: 10.3892/ol.2020.11881. Epub 2020 Jul 16.
Chimeric antigen receptor (CAR)-T cell therapy is a novel cellular immunotherapy for relapsed/refractory(R/R) B acute lymphoblastic leukemia (B-ALL). However, the survival duration of CAR-T cells is noteworthy, and in some cases recurrence occurs following CAR-T cell therapy. There is controversy over the benefits of bridging to allo-HSCT after CAR-T cell therapy. The present study explored the efficacy and safety of CD19 chimeric antigen receptor (CAR) T-bridged allogeneic hematopoietic stem cell transplantation (allo-HSCT) treatment in relapsed/refractory B-cell acute lymphocytic leukemia (R/R B-ALL). A total of 9 patients with B-ALL treated at The First Affiliated Hospital of Wenzhou Medical University between December 2016 and November 2017 were included. The results demonstrated that the total response rate on day 28 after receiving CD19-CAR T-cell therapy was 100% (9/9) and all patients exhibited complete remission. The 1-year overall survival (OS) rate for 5 patients who received CAR-T bridged HSCT was 100%, the 1-year DFS rate was 100%; the 1-year OS rate for the 4 patients who received CAR-T therapy was 75%, and the 1-year DFS rate was 75%. Patients who received CAR-T bridged to HSCT had no significant prolongation of myeloid and platelet engraftment median time compared with patients who received CAR-T alone, and the incidence of acute graft-versus-host disease or extensive chronic graft-versus-host disease did not increase. Overall, the present clinical trial demonstrated that CAR-T therapy bridging to HSCT is a feasible, safe and effective method to treat adult patients with R/R B-ALL.
嵌合抗原受体(CAR)-T细胞疗法是一种针对复发/难治性(R/R)B细胞急性淋巴细胞白血病(B-ALL)的新型细胞免疫疗法。然而,CAR-T细胞的存活时间值得关注,在某些情况下,CAR-T细胞治疗后会出现复发。CAR-T细胞治疗后进行异基因造血干细胞移植(allo-HSCT)的益处存在争议。本研究探讨了CD19嵌合抗原受体(CAR)T细胞桥接异基因造血干细胞移植(allo-HSCT)治疗复发/难治性B细胞急性淋巴细胞白血病(R/R B-ALL)的疗效和安全性。纳入了2016年12月至2017年11月在温州医科大学附属第一医院接受治疗的9例B-ALL患者。结果显示,接受CD19-CAR T细胞治疗后第28天的总缓解率为100%(9/9),所有患者均表现为完全缓解。5例接受CAR-T桥接HSCT患者的1年总生存率(OS)为100%,1年无病生存率(DFS)为100%;4例接受CAR-T治疗患者的1年OS率为75%,1年DFS率为75%。与单纯接受CAR-T治疗的患者相比,接受CAR-T桥接HSCT的患者髓系和血小板植入中位时间无显著延长,急性移植物抗宿主病或广泛慢性移植物抗宿主病的发生率也未增加。总体而言,本临床试验表明,CAR-T治疗桥接HSCT是治疗成年R/R B-ALL患者的一种可行、安全且有效的方法。