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    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY
    1.
    发明公开
    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY 有权
    加药给药的CD19xCD3双特异性抗体。

    公开(公告)号：EP2493503A1

    公开(公告)日：2012-09-05

    申请号：EP10771102.0

    申请日：2010-10-27

    申请人： Amgen Research (Munich) GmbH

    发明人： NAGORSEN, Dirk ,  KUFER, Peter ,  ZUGMAIER, Gerhard ,  BAEUERLE, Patrick

    IPC分类号： A61K39/395 ,  C07K16/46 ,  G01N33/574

    CPC分类号： C07K16/2809 ,  A61K2039/505 ,  A61K2039/545 ,  A61K2039/55 ,  C07K16/2803 ,  C07K2317/31 ,  G01N33/505 ,  G01N33/5052 ,  G01N33/5094 ,  G01N2800/52

    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. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19x CD3 bispecific antibody to a human patient having a B :T cell ratio of about 1:5 or lower, 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 CD19x CD3 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.