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Last Updated: March 29, 2024

Claims for Patent: 9,688,760


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Summary for Patent: 9,688,760
Title:Anti-leukocyte adhesion for the mitigation of potential adverse events caused by CD3-specific binding domains
Abstract: The present invention relates in essence to use of a compound, which decreases or inhibits the binding of mammalian T-cells to mammalian endothelial cells for use in a method of prophylaxis and/or amelioration and/or treatment of clinical adverse events caused by a therapy which comprises re-directing of T-cells against target cells in a patient. Such a therapy includes, but is not limited to, treatment with an antibody comprising a CD3 binding domain, such as a CD20.times.CD3 or a CD19.times.CD3 bispecific single chain antibody, e.g., blinatumomab (MT-103). Methods of treatment of patients having or being at risk of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells are also contemplated, as are methods of identifying a compound for administration in the methods of prophylaxis, amelioration and/or treatment. Such anti-adhesive type compounds include, but are not limited to, antibodies, like natalizumab, efalizumab, and etrolizumab; minocycline, (acetyl-)salicyclic acid, astilbin, and flavonoids; and thrombin and pentosanpolysulfate (PPS), or a pharmaceutically acceptable salt thereof.
Inventor(s): Kufer; Peter (Munich, DE), Nagorsen; Dirk (Munich, DE), Scheele; Juergen (Munich, DE), Zugmaier; Gerhard (Munich, DE), Klinger; Matthias (Gilching, DE), Hoffmann; Patrick (Bad Heilbrunn, DE), Naegele; Virginie (Munich, DE), Dopfer; Elaine-Pashupati (Munich, DE)
Assignee: AMGEN RESEARCH (MUNICH) GMBH (Munich, DE)
Application Number:14/176,091
Patent Claims:1. A method of ameliorating, treating, or preventing a clinical adverse event in a patient caused by administering blinatumomab to the patient, the method comprising administering to the patient an effective amount of pentosanpolysulfate (PPS) or a pharmaceutically acceptable salt thereof, minocycline, or natalizumab.

2. The method according to claim 1, wherein the method further comprises administering to the patient genetically engineered T-cells having a chimeric antigen receptor (CAR).

3. The method according to claim 2, wherein said chimeric antigen receptor (CAR) comprises a CD19 binding domain.

4. The method according to claim 1, wherein the pentosanpolysulfate (PPS) or the pharmaceutically acceptable salt thereof, minocycline, or natalizumab is administered prior to or concomitantly with an initial dosing, a re-exposure, or an increase in dose of blinatumomab.

5. The method according to claim 1, wherein said clinical adverse event comprises a neurological adverse event.

6. The method according to claim 5, wherein said neurological adverse event is one or more of (i) a cognitive disorder comprising disorientation, confusion or word-finding problems (aphasia), (ii) a seizure, (iii) a cerebellar symptom partly observed as an optional prodromal phase of (i) or (ii) comprising a kinetic tremor, ataxia, dysarthria and/or handwriting problems.

7. The method according to claim 1, wherein said patient is characterized by a B:T-cell ratio of less than 1:5 or a B-cell number of less than about 50 B-cells per .mu.l peripheral blood.

8. The method according to claim 1, wherein said patient is a mammal.

9. The method according to claim 8, wherein said mammal is a primate.

10. The method according to claim 9, wherein said primate is a human.

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