Dosing of a bispecific antibody that bind cd123 and cd3
AssigneeNovartis AG
InventorsMichael Wayne SAVILLE, Paul FOSTER
Life of this patent
Estimating the term…
Abstract
The methods described here are directed to treating human subjects with bispecific anti-CD 123×anti-CD3 antibodies.
Claims61
A method for treating a CD123-expressing cancer in a human subject in need of treatment thereof, comprising administering to the human subject a bispecific anti-CD123×anti-CD3 antibody in at least a first and a second phase,
- wherein during the first phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 700 ng/kg and about 1,900 ng/kg, once a week, for one or two weeks, and
- wherein during the second phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 2,000 ng/kg and about 5,000 ng/kg, once a week, for at least one week.
The method of any one of claims 13 to 16, wherein the maintenance dose is administered once every three or four weeks or once a month for at least one dose.
The method of any one of claims 1 to 4 and 24 to 35, consisting essentially of a first phase and a second phase,
- wherein the first phase is one week, and
- wherein during the second phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 2,200 ng/kg and about 2,400 ng/kg, once a week, until remission.
A method for treating a CD123-expressing cancer in a human subject in need of treatment thereof, comprising administering to the human subject a bispecific anti-CD123×anti-CD3 antibody in at least a first phase and a second phase and a third phase,
- wherein during the first phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 300 ng/kg and about 1,100 ng/kg, three times a week, for one week, with the proviso that the first dose amount of the first phase is not greater than about 770 ng/kg,
- wherein during the second phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 300 ng/kg and about 1,100 ng/kg, three times a week, for one week, and
- wherein during the third phase, the bispecific anti-CD123×anti-CD3 antibody is administered to the human subject in an amount of between about 900 ng/kg and about 3,400 ng/kg, once a week for at least one week.
A method for treating a CD123-expressing cancer in a human subject in need of treatment thereof, comprising administering to the human subject a bispecific anti-CD123×anti-CD3 antibody in an amount of between about 900 ng/kg and about 3,400 ng/kg, once a week for at least one week.
Dependencies are inferred from the claim text.