Dosage regimen for administering a CD19XCD3 bispecific antibody

US10662243B2 · kind B2 · utility

Assignee

• AMGEN RESEARCH (MUNICH) GMBH · DE

Inventors

• Dirk Nagorsen · Munich, DE
• Peter Kufer · Munich, DE
• Gerhard Zugmaier · Munich, DE
• Patrick Bauerle · Gauting, DE

Key dates

• Filing date: Sep 19, 2014
• Grant date: May 26, 2020
• Expiry date: Sep 19, 2034

Classification

• Technology area (CPC G): Physics
• CPC primary: G01N2800/52
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The disclosure provides a method for assessing 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. The disclosure also provides a method for administering a CD19×CD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower, comprising administering doses in a dosing regimen. This dosing 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 Also provided is a pharmaceutical package or kit comprising a first dose and a second dose and optionally a third dose of said antibody.