肿瘤细胞治疗研究
英文原题：Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial.
约30%对axicabtagene ciloleucel（axi-cel；靶向CD19的嵌合抗原受体（CAR）T细胞疗法）有应答的复发或难治性大B细胞淋巴瘤（LBCL）患者会出现CD19阴性复发。
约30%对axicabtagene ciloleucel（axi-cel；靶向CD19的嵌合抗原受体（CAR）T细胞疗法）有应答的复发或难治性大B细胞淋巴瘤（LBCL）患者会出现CD19阴性复发。在这项2期单臂研究中，26名化疗难治性LBCL参与者接受了axi-cel联合利妥昔单抗治疗。主要终点是研究者评估的完全缓解率；选定的次要终点包括缓解持续时间（DOR）、axi-cel药代动力学和安全性。完全缓解率为73%。中位DOR为26.0个月；46%的参与者在数据截止时仍有持续缓解。在完全缓解或持续缓解的参与者中，CAR T细胞峰值（按肿瘤负荷归一化）和利妥昔单抗曲线下面积水平升高。axi-cel联合利妥昔单抗治疗带来了持久缓解，尽管存在持续性B细胞再生障碍，但未出现新的安全性信号，且axi-cel的药代动力学未受影响，这表明CD19和CD20双靶向是一种可行且安全的方法，有可能限制抗原逃逸。ClinicalTrials.gov注册号：NCT04002401。
CD19-negative relapse occurs in ~30% of persons with relapsed or refractory large B cell lymphoma (LBCL) who respond to axicabtagene ciloleucel (axi-cel; CD19-directed chimeric antigen receptor (CAR) T cell therapy). In this phase 2 single-arm study, 26 participants with chemorefractory LBCL received axi-cel in combination with rituximab. The primary endpoint was investigator-assessed complete response rate; select secondary endpoints included duration of response (DOR), axi-cel pharmacokinetics and safety. The complete response rate was 73%. Median DOR was 26.0 months; 46% of participants had an ongoing response at data cutoff. Peak CAR T cell (normalized by tumor burden) and rituximab area-under-the-curve levels were elevated in participants with complete or ongoing response. Axi-cel plus rituximab treatment led to durable responses with no new safety signals despite persistent B cell aplasia and pharmacokinetics of axi-cel were unaffected, indicating that dual targeting of CD19 and CD20 is a feasible and safe approach to potentially limit antigen escape. ClinicalTrials.gov registration: NCT04002401 .
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