发明名称 |
DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY |
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 CD19×CD3 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 CD19×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 CD19×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. |
申请公布号 |
HRP20151196(T1) |
申请公布日期 |
2015.12.18 |
申请号 |
HR2015P001196T |
申请日期 |
2015.11.09 |
申请人 |
AMGEN RESEARCH (MUNICH) GMBH |
发明人 |
NAGORSEN, DIRK;KUFER, PETER;ZUGMAIER, GERHARD;BAEUERLE, PATRICK |
分类号 |
A61K39/00;C07K16/28;G01N33/50 |
主分类号 |
A61K39/00 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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