KTE-X19汽车t细胞治疗复发或难治性套细胞淋巴瘤。

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王米,穆尼奥斯J,异教徒,洛克FL,雅各布森CA,希尔BT, Timmerman JM,福尔摩斯H, Jaglowski年代,Flinn信息战,筹划PA,米DB,由此JM, Kersten MJ, Milpied N, Fung H, Topp女士,Houot R, Beitinjaneh,彭W,郑L,罗西JM, Jain RK,饶AV,里根点

KTE-X19汽车t细胞治疗复发或难治性套细胞淋巴瘤。

郑传经地中海J。2020年4月2;382 (14):1331 - 1342。doi: 10.1056 / NEJMoa1914347。

PubMed ID
32242358 (在PubMed
]
文摘

背景:复发或难治性套细胞淋巴瘤患者疾病进展期间或之后收到布鲁顿的酪氨酸激酶(对)杀人案抑制剂治疗预后不佳。KTE-X19, anti-CD19嵌合抗原受体(汽车)t细胞疗法,可能复发或难治性套细胞淋巴瘤患者受益。方法:多中心,第二阶段试验中,我们评估KTE-X19患者复发或难治性套细胞淋巴瘤。患者疾病复发或难治性收据后5以前的治疗;所有的患者必须接受对抑制剂治疗杀人案。病人接受leukapheresis和可选的桥接治疗,其次是调节化疗和一个KTE-X19注入剂量的2 x10(6)汽车T细胞每公斤体重。主要终点是客观的反应患者的百分比(完全或部分响应)作为评估由一个独立的放射审查委员会根据卢加诺分类。每个协议的主要功效进行分析后60名患者治疗和随访7个月。结果:共有74名患者参与。KTE-X19是68年制造的71名患者和管理。 The primary efficacy analysis showed that 93% (95% confidence interval [CI], 84 to 98) of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53 to 78) had a complete response. In an intention-to-treat analysis involving all 74 patients, 85% had an objective response; 59% had a complete response. At a median follow-up of 12.3 months (range, 7.0 to 32.3), 57% of the 60 patients in the primary efficacy analysis were in remission. At 12 months, the estimated progression-free survival and overall survival were 61% and 83%, respectively. Common adverse events of grade 3 or higher were cytopenias (in 94% of the patients) and infections (in 32%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 15% and 31% of patients, respectively; none were fatal. Two grade 5 infectious adverse events occurred. CONCLUSIONS: KTE-X19 induced durable remissions in a majority of patients with relapsed or refractory mantle-cell lymphoma. The therapy led to serious and life-threatening toxic effects that were consistent with those reported with other CAR T-cell therapies. (Funded by Kite, a Gilead company; ZUMA-2 ClinicalTrials.gov number, NCT02601313.).

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药物
药物靶点
药物 目标 类 生物 药理作用 行动
Brexucabtagene autoleucel 淋巴球抗原CD19 蛋白质 人类
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