US 11,987,636 B2
Dosing of a bispecific antibody that binds CD20 and CD3
David Liebowitz, San Diego, CA (US)
Assigned to XENCOR, INC., Pasadena, CA (US)
Filed by XENCOR, INC., Pasadena, CA (US)
Filed on Jun. 3, 2022, as Appl. No. 17/832,093.
Claims priority of provisional application 63/197,218, filed on Jun. 4, 2021.
Prior Publication US 2023/0048390 A1, Feb. 16, 2023
Int. Cl. C07K 16/28 (2006.01); A61P 35/00 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/2887 (2013.01) [A61P 35/00 (2018.01); C07K 16/2809 (2013.01); A61K 2039/545 (2013.01); C07K 2317/31 (2013.01); C07K 2317/565 (2013.01)] 20 Claims
 
1. A method for treating a human subject with a CD20-expressing cancer, comprising:
administering to the human subject a bispecific anti-CD20×anti-CD3 antibody in a first phase, a second phase, a third phase, a fourth phase, and a fifth phase,
wherein in the first phase the bispecific anti-CD20×anti-CD3 antibody is administered once to the human subject in a first phase dose amount between about 0.5 mg and about 1.1 mg,
in the second phase the bispecific anti-CD20×anti-CD3 antibody is administered once to the human subject in a second phase dose amount between about 1.5 mg and about 2.5 mg,
in the third phase the bispecific anti-CD20×anti-CD3 antibody is administered once to the human subject in a third phase dose amount between about 18 mg and about 22 mg,
in the fourth phase the bispecific anti-CD20×anti-CD3 antibody is administered once to the human subject in a fourth phase dose amount between about 30 mg and about 55 mg,
in the fifth phase the bispecific anti-CD20×anti-CD3 antibody is administered at least once to the human subject in a fifth phase dose amount between about 45 mg and about 55 mg,
wherein the time period between each administration is about 6 to about 8 days, wherein each of the first phase dose amount to the fifth phase dose amount is independent of the weight of the human subject, and
wherein the bispecific anti-CD20×anti-CD3 antibody comprises a first polypeptide comprising the amino acid sequence of SEQ ID NO:1, a second polypeptide comprising the amino acid sequence of SEQ ID NO: 2, and a third polypeptide comprising the amino acid sequence of SEQ ID NO: 3.