NEJM:抗B细胞成熟抗原CAR-T细胞疗法bb2121治疗多发性骨髓瘤的效果

2021-05-10 MedSci原创 MedSci原创

bb2121是一种抗B细胞成熟抗原(BCMA)的嵌合抗原受体(CAR)T细胞疗法。临床前研究提示bb2121具有治疗多发性骨髓瘤的潜力。近日,一项1期研究中,研究人员进一步探究了bb2121治疗多发性

bb2121是一种抗B细胞成熟抗原(BCMA)的嵌合抗原受体(CAR)T细胞疗法。临床前研究提示bb2121具有治疗多发性骨髓瘤的潜力。近日,一项1期研究中,研究人员进一步探究了bb2121治疗多发性骨髓瘤的效果,研究结果已发表于N Engl J Med。

研究纳入复发性或难治性多发性骨髓瘤患者,在剂量递增阶段,以单次输入形式给予患者剂量为:50×106、150×106、450×106 或800×106的CAR阳性(CAR+)T细胞。在扩展阶段,给予患者150×106~450×106 CAR+T细胞,患者既往至少接受过三线疗法,包括一种蛋白酶体抑制剂和一种免疫调节剂,或者对两类药物都有耐药性,主要终点为安全性。

 

该研究报告了最早接受bb2121输入的连续33例患者的结果。数据截止日期为最后一次输入日期后的6.2个月。最常见的3级或更高级别事件是血液学毒性作用,包括中性粒细胞减少(85%)、白细胞减少(58%)、贫血(45%)和血小板减少(45%)。

 

试验过程中,共有25例患者(76%)出现了细胞因子释放综合征,其中23例(70%)为1或2级,2例(6%)的为3级。14例患者(42%)出现神经毒性作用,其中13例(39%)为1或2级。1例患者(3%)出现了可逆的4级神经毒性作用。客观缓解率为85%,包括完全缓解的15例患者(45%)。在完全缓解的15例患者中,6例复发。

 

中位无进展生存期为11.8个月(95% 置信区间,6.2~17.8)。所有16名缓解(部分缓解或更好)且能被评估为最小残留疾病(MRD)的患者均为MRD阴性状态(≤10-4个有核细胞)。CAR T细胞扩增与缓解相关,且CAR T细胞持续至输入后长达1年。

综上所述,该研究报告了复发性或难治性多发性骨髓瘤患者接受靶向BCMA的细胞免疫疗法后显示出的初步毒性特征,研究证实了bb2121的抗肿瘤活性。

 

原始出处:

 

Noopur Raje, et al., Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

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    2022-02-24 仁者大医
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    2021-08-17 jml2009
  4. 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  5. 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content=<a href='/topic/show?id=62a655263e9' target=_blank style='color:#2F92EE;'>#抗原#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55263, encryptionId=62a655263e9, topicName=抗原)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed May 12 11:58:51 CST 2021, time=2021-05-12, status=1, ipAttribution=)]
    2021-06-03 ms8000001077095058

    0

  6. 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content=<a href='/topic/show?id=62a655263e9' target=_blank style='color:#2F92EE;'>#抗原#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55263, encryptionId=62a655263e9, topicName=抗原)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed May 12 11:58:51 CST 2021, time=2021-05-12, status=1, ipAttribution=)]
    2021-05-13 汉水人家

    学习学习

    0

  7. 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抗B细胞成熟抗原(BCMA)嵌合抗原受体(CAR)T细胞疗法已被证明对复发或难治性多发性骨髓瘤患者具有活性。有报告表明,一小部分分化程度较低的骨髓瘤克隆表达CD19,而抗CD19的CAR T细胞疗法对

JCO:伊沙佐米+达雷木单抗+地塞米松用于多发性骨髓瘤体弱患者的疗效和安全性

新确诊多发性骨髓瘤的体弱患者的预后往往较差,主要是因为这类患者常不能耐受治疗的副作用而导致治疗高中断率