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    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY TO PATIENTS AT RISK FOR POTENTIAL ADVERSE EFFECTS
    74.
    发明公开
    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY TO PATIENTS AT RISK FOR POTENTIAL ADVERSE EFFECTS 审中-公开
    加药施用的双特异性为CD19xCD3抗体的患者风险TO可能的副作用

    公开(公告)号：EP2701741A1

    公开(公告)日：2014-03-05

    申请号：EP12724289.9

    申请日：2012-04-30

    申请人： Amgen Research (Munich) GmbH

    发明人： NAGORSEN, Dirk

    IPC分类号： A61K39/395 ,  A61P35/02 ,  C07K16/28

    CPC分类号： G01N33/5094 ,  A61K2039/505 ,  A61K2039/507 ,  C07K16/2803 ,  C07K16/2809 ,  C07K2317/31 ,  C07K2317/622

    摘要： The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19xCD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient or determining the total B cell count of said patient, wherein a total B cell count of less than about 50 B cells per microliter of peripheral blood is indicative for a risk of potential adverse effects for said patient. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19xCD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower and/or a total B cell count of less than about 50 B cells per microliter of peripheral blood, comprising (a) administering a first dose of said antibody for a first period of time; and consecutively (b) administering a second dose of said antibody for a second period of time, wherein said second dose exceeds said first dose. In some embodiments, a third dose of said antibody is administered for a third period of time. This dosage regimen can be applied in methods for treating malignant CD19 positive lymphocytes or for ameliorating and/or preventing an adverse effect mediated by the administration of said bispecific antibody. The present invention also relates to the use of a CD19xCD3 bispecific antibody for the preparation of a pharmaceutical composition to be used in a method of the present invention. A pharmaceutical package or kit comprising a first dose and a second dose and optionally a third dose of said antibody as defined in the methods/dosage regimen of the present invention is disclosed as well.

    摘要翻译： 本发明涉及一种用于assesing（分析）的潜在不良作用的风险通过CD19xCD3双特异性抗体对所述患者施用介导的包括确定性采矿B细胞以T表示患者的细胞的比例的人患者，worin一个 比约为1：5或更低是指示用于所述患者或确定性采矿所述患者的总B细胞计数，每微升外周血是worin小于约50的B细胞的总B细胞计数潜在不良反应的风险 指示对所述患者的潜在不良反应的风险。 因此，本发明涉及的方法（给药方案）给予CD19xCD3双特异性抗体给人类患者具有B：T细胞比率为约1：5或更低和/或小于约50 B的总B细胞计数 每微升外周血的细胞，其包含（a）给予所述抗体的第一剂量的第一时间段; 和连续地（b）施用所述抗体的第二剂量的第二时间段，worin所述第二剂量超过所述第一剂量。 在一些实施方案中，所述抗体的第三剂量给药的时间的第三时间段。 该剂量方案可以在方法施加用于治疗恶性CD19阳性淋巴细胞或用于改善和/或由所述双特异性抗体的施用介导的不良影响防止。 因此，本发明涉及使用CD19xCD3双特异性抗体用于制备药物组合物的制备在本发明的方法中使用。 一种药物包装或试剂盒，其包括第一剂量和第二剂量和任选的所述抗体的第三剂量如在本发明的方法/给药方案定义是游离缺失盘为好。