肿瘤细胞治疗研究
英文原题：AFM13 in patients with relapsed or refractory classical Hodgkin lymphoma: final results of an open-label, randomized, multicenter phase II trial.
由于入组缓慢，该试验在治疗 25 例患者后终止。
经典霍奇金淋巴瘤（cHL）患者在自体干细胞移植、brentuximab vedotin及抗PD-1治疗后复发，预后较差。为评估双特异性抗CD30/CD16A NK细胞衔接抗体AFM13的疗效并确定最佳治疗方案（A至C组），研究者启动了一项随机、两阶段II期试验（NCT02321592）。由于招募缓慢，25例患者接受治疗后试验终止。AFM13耐受性良好，仅报告2例治疗相关严重不良事件（SAE），且均完全缓解。所有可评估患者中，客观缓解率（ORR）为16.7%（A组1/5、B组1/11、C组2/8），12个月无进展生存率（PFS）为12.6%（95% CI：3.2至28.9），AFM13单药治疗疗效有限。持续给药方案（C组）可能效果更好，但就诊安排应更贴合患者日常生活。
In patients with relapse of classical Hodgkin lymphoma (cHL) after autologous stem cell transplant, brentuximab vedotin and anti-PD1 treatment, the outcome is poor. To assess the efficacy of the bispecific anti-CD30/CD16A, NK-cell engaging antibody AFM13 and to select the optimal treatment schedule (arm A-C), we initiated a randomized two-stage phase II trial (NCT02321592). Due to slow recruitment, the trial was terminated after treatment of 25 patients. Treatment with AFM13 was well tolerated: only two treatment-associated serious adverse events (SAEs) were reported; all SAEs resolved completely. With an objective response rate (ORR) of 16.7% (1/5 in arm A, 1/11 in arm B, and 2/8 in arm C) and a 12-month progression-free survival (PFS) of 12.6% (95% CI 3.2-28.9), treatment efficacy of AFM13 monotherapy in all evaluable patients was modest. The continuous application schedule (arm C) might be more effective, but the visit schedule should be better aligned with patients' daily life.
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