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filingDate 2010-10-27-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2016-07-07-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2016-07-07-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AU-2010311559-B2
titleOfInvention Dosage regimen for administering a CD19xCD3 bispecific antibody
abstract 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.
priorityDate 2009-10-27-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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