Patent ID: 11858995
Assignee: GENMAB A/S
Field: Pharmaceuticals (Chemistry)
Classification: CPC C  A | IPC A  C

Claim 0:
1. A method of treating chronic lymphocytic leukemia (CLL) in a human subject, the method comprising subcutaneously administering to the subject a bispecific antibody comprising:
(i) a first binding arm comprising a first antigen-binding region which binds to human CD3ε (epsilon) and comprises a variable heavy chain (VH) region and a variable light chain (VL) region, wherein the VH region comprises the CDR1, CDR2 and CDR3 sequences that are in the VH region sequence of SEQ ID NO: 6, and the VL region comprises the CDR1, CDR2 and CDR3 sequences that are in the VL region sequence of SEQ ID NO: 7; and
(ii) a second binding arm comprising a second antigen-binding region which binds to human CD20 and comprises a VH region and a VL region, wherein the VH region comprises the CDR1, CDR2 and CDR3 sequences that are in the VH region sequence of SEQ ID NO: 13, and the VL region comprises the CDR1, CDR2 and CDR3 sequences that are in the VL region sequence of SEQ ID NO: 14;
wherein the bispecific antibody is administered at a full dose ranging from 12-60 mg in 28-day cycles, and wherein a priming dose of the bispecific antibody is administered on day 1 of cycle 1, and an intermediate dose of the bispecific antibody is administered on day 8 of cycle 1 before administration of the first full dose of the bispecific antibody on day 15 of cycle 1, wherein the priming dose and intermediate dose are at a lower dose as compared with the full dose; and
wherein administration of the full dose of the bispecific antibody continues at least until the subject exhibits a complete response (CR), a partial response (PR) or stable disease, or until progressive disease develops or unacceptable toxicity occurs.