Objective: To investigated the safety and efficacy of donor-derived CD19+ or sequential CD19+ CD22+ chimeric antigen receptor T-cell (CAR-T) therapy in patients with B-cell acute lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods: The data of 22 patients with B-ALL who relapsed after allo-HSCT and who underwent donor-derived CAR-T therapy at the Zhujiang Hospital of Southern Medical University and the 920th Hospital of Joint Logistics Support Force of the People's Liberation Army of China from September 2015 to December 2022 were retrospectively analyzed. The primary endpoint was overall survival (OS), and the secondary endpoints were event-free survival (EFS), complete remission (CR) rate, and Grade 3-4 adverse events. Results: A total of 81.82% (n=18) of the 22 patients achieved minimal residual disease-negative CR after CAR-T infusion. The median follow-up time was 1037 (95% CI 546-1509) days, and the median OS and EFS were 287 (95% CI 132-441) days and 212 (95% CI 120-303) days, respectively. The 6-month OS and EFS rates were 67.90% (95% CI 48.30%-84.50%) and 58.70% (95% CI 37.92%-79.48%), respectively, and the 1-year OS and EFS rates were 41.10% (95% CI 19.15%-63.05%) and 34.30% (95% CI 13.92%-54.68%), respectively. Grade 1-2 cytokine release syndrome occurred in 36.36% (n=8) of the patients, and grade 3-4 occurred in 13.64% of the patients (n=3). Grade 2 and 4 graft-versus-host disease occurred in two patients. Conclusion: Donor-derived CAR-T therapy is safe and effective in patients with relapsed B-ALL after allo-HSCT.
目的： 探索供者来源靶向CD19或联合靶向CD22嵌合抗原受体T细胞（CAR-T细胞）治疗异基因造血干细胞移植后复发急性B淋巴细胞白血病（B-ALL）的有效性及安全性。 方法： 回顾性分析2015年9月至2022年12月在南方医科大学珠江医院及解放军联勤保障部队第九二〇医院血液科22例接受供者来源CAR-T细胞治疗的异基因造血干细胞移植后复发的B-ALL患者的有效性和安全性。主要研究终点是总生存（OS），次要研究终点是无事件生存（EFS）、完全缓解（CR）率、3～4级不良事件。 结果： CAR-T细胞输注后，18例（81.82%）患者获得CR且微小残留病（MRD）均为阴性。中位随访1037（95%CI 546～1509）d，中位OS期为287（95%CI 132～441）d，中位EFS期为212（95%CI 120～303）d，6个月OS率为67.90%（95%CI 48.30%～84.50%），6个月EFS率为58.70%（95%CI 37.92%～79.48%），1年OS率为41.10%（95%CI 19.15%～63.05%），1年EFS率为34.30%（95%CI 13.92%～54.68%）。3例（13.64%）患者发生≥3级细胞因子释放综合征（CRS），未发生免疫效应细胞相关神经毒性综合征（ICANS），2例患者发生急性移植物抗宿主病（aGVHD）（分别为Ⅱ度和Ⅳ度）。 结论： 供者来源CAR-T细胞治疗异基因造血干细胞移植后复发B-ALL是一种安全有效的治疗策略。.
Keywords: Allogeneic hematopoietic stem cell transplantation; B-cell acute lymphoblastic leukemia; Chimeric antigen receptor; Donor-derived; Relapsed.