In patients diagnosed with B-acute lymphoblastic leukemia (B-ALL) or B-non-Hodgkin’s lymphoma (B-NHL) relapsing after allogeneic stem cell transplantation (allo-HCT), it is a standard practice to perform anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. When collected from the patient after allo-HCT, the produced CAR-T cells are likely to be donor T-cell-derived, creating unknown safety risks due to their potential allo-reactivity. We therefore performed an EBMT registry-based study on the incidence of graft-versus-host disease (GvHD) in this setting. We included 257 allo-HCT patients (n = 172 ≥ 18 years) with B-ALL or B-NHL, treated with anti-CD19 CAR T-cells (tisagenlecleucel n = 184, brexucabtagene autoleucel n = 43 and axicabtagene ciloleucel n = 30), between 2018 and 2022. Three patients developed aGvHD, whereas 6 patients developed cGvHD after CAR T-cell. The 100-day cumulative incidence (CI) of new aGvHD was 1.6% and the 12-month CI of new cGvHD was 2.8%. The 1-year GvHD relapse-free survival and non-relapse mortality were 52.1% and 4.7%, respectively. Last, with a median follow up of 18.8 months, the 1-year overall survival was 76.8%. In summary, the GvHD rate in allo-HCT patients treated with CAR T-cell therapy is relatively low. Our data support the view that GvHD is not a major safety issue in this setting.

对于诊断为 B 级急性淋巴细胞白血病 （B-ALL） 或 B 级非霍奇金淋巴瘤 （B-NHL） 的患者在同种异体干细胞移植 （allo-HCT） 后复发，进行抗 CD19 嵌合抗原受体 （CAR） T 细胞治疗是一种标准做法。当在同种异体 HCT 后从患者身上收集时，产生的 CAR-T 细胞很可能是供体 T 细胞来源的，由于其潜在的同种异体反应性，会造成未知的安全风险。因此，我们进行了一项基于 EBMT 登记的研究，研究了在这种情况下移植物抗宿主病 （GvHD） 的发生率。我们纳入了 2018 年至 2022 年间 257 例接受抗 CD19 CAR T 细胞治疗 （tisagenlecleucel n = 184、brexucabtagene autoleucel n = 43 和 axicabtagene ciloleucel n = 30） 的 B-ALL 或 B-NHL 同种异体 HCT 患者 （n = 172 ≥ 18 岁）。3 例患者发生 aGvHD，而 6 例患者在 CAR T 细胞后发生 cGvHD。新发 aGvHD 的 100 天累积发生率 （CI） 为 1.6%，新发 cGvHD 的 12 个月 CI 为 2.8%。1 年 GvHD 无复发生存率和非复发死亡率分别为 52.1% 和 4.7%。最后，中位随访 18.8 个月，1 年总生存率为 76.8%。总之，接受 CAR T 细胞疗法治疗的同种异体 HCT 患者的 GvHD 率相对较低。我们的数据支持这样的观点，即 GvHD 在这种情况下不是一个主要的安全问题。