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US 11,633,408 B2Granted
Prevention of adverse effects caused by CD3 specific binding domains
AssigneeAmgen Research (Munich) GmbH
InventorsGerhard Zugmaier, Dirk Nagorsen, Juergen Scheele
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Abstract
The present invention relates to a glucocorticoid (GC) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a CD3 binding domain. Kits comprising a GC, a CD3 binding domain and instructions for use which indicate that the GC is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.
Claims16
A method for preventing, ameliorating, or treating an adverse neurological event in a subject,
- wherein the adverse neurological event is confusion, loss of memory, ataxia, speech disorder, disorientation, seizures, encephalopathy, cerebral edema, hallucinations, apraxia, paresis, or tremor caused by administering to the subject an antibody or fragment thereof comprising a CD3 binding domain comprising an anti-CD3 heavy chain comprising a CDR-H1 comprising the amino acid sequence of SEQ ID NO:
- 11, a CDR-H2 comprising the amino acid sequence of SEQ ID NO:
- 12, and a CDR-H3 comprising the amino acid sequence of SEQ ID NO:
- 13, and an anti-CD3 light chain comprising a CDR-L1 comprising the amino acid sequence of SEQ ID NO:
- 14, a CDR-L2 comprising the amino acid sequence of SEQ ID NO:
- 15, and a CDR-L3 comprising the amino acid sequence of SEQ ID NO:
- 16,
- the method comprising the step of administering an effective amount of a glucocorticoid (GC) to the subject prior to or concurrently with administering a first dose of the antibody or fragment thereof comprising the CD3 binding domain, and prior to the presence of the adverse neurological event in the subject.
5 more elements
Dependencies are inferred from the claim text.