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 of a 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.
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申请公布号 |
US2012328618(A1) |
申请公布日期 |
2012.12.27 |
申请号 |
US201013504665 |
申请日期 |
2010.10.27 |
申请人 |
NAGORSEN DIRK;KUFER PETER;ZUGMAIER GERBACH;BAEUERLE PATRICK;MICROMET AG |
发明人 |
NAGORSEN DIRK;KUFER PETER;ZUGMAIER GERBACH;BAEUERLE PATRICK |
分类号 |
A61K39/395;A61P35/00;A61P35/02 |
主分类号 |
A61K39/395 |
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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