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US 2024/0181052 A1Published application
Methods for dosing and treatment with a combination of a checkpoint inhibitor therapy and a car t cell therapy
AssigneeJuno Therapeutics, Inc.
InventorsNikolaus Sebastian TREDE, Satyendra SURYAWANSHI, Shruti AGRAWAL, Shivani SRIVASTAVA, Tim PULHAM, Joe DESTEFANO, Nicolas BRAND, Ronald DUBOWY
Life of this patent
Estimating the term…
Abstract
Provided herein are methods and uses of combination therapies involving a T cell therapy, e.g., a CAR T cell therapy, and a checkpoint inhibitor therapy, e.g. an anti-PD-1 antibody and/or an anti-LAG3 antibody, for treating subjects with cancers such as lymphomas, and related methods, uses, and articles of manufacture.
Claims141
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering a PD-1 inhibitor to the subject;
- and
- (3) administering a LAG3 inhibitor to the subject.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- (2) administering a PD-1 inhibitor to the subject;
- and
- (3) administering a LAG3 inhibitor to the subject.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each dose of the PD-1 inhibitor is between at or about 140 mg and at or about 580 mg, inclusive.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each dose of the PD-1 inhibitor is between at or about 140 mg and at or about 580 mg, inclusive.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each subsequent dose of the PD-1 inhibitor is administered about two weeks, about three weeks, or about four weeks after the previous dose of the PD-1 inhibitor.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each subsequent dose of the PD-1 inhibitor is administered about two weeks, about three weeks, or about four weeks after the previous dose of the PD-1 inhibitor.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 8, 22, 36, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg of the LAG3 inhibitor on Days 8, 36, and 71.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 15, 29, 43, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg on Days 15, 43, and 71.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 8, 22, 36, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg of the LAG3 inhibitor on Days 8, 22, 36, 57, 71, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 15, 29, 43, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg of the LAG3 inhibitor on Days 815, 29, 43, 57, 71, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising:
- (i) administration of a first amount of the PD-1 inhibitor, wherein the first amount is 240 mg and is administered on Days 8, 22, and 36;
- and
- (ii) administration of a second amount of the PD-1 inhibitor, wherein the second amount is 480 mg and is administered on Days 57 and 85.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising:
- (i) administration of a first amount of the PD-1 inhibitor, wherein the first amount is 240 mg and is administered on Days 15, 29, and 43;
- and
- (ii) administration of a second amount of the PD-1 inhibitor, wherein the second amount is 480 mg and is administered on Days 57 and 85.
3 more elements
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 8, 22, 36, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 120 mg of the LAG3 inhibitor on Days 8, 22, 36, 57, 71, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 240 mg of the PD-1 inhibitor on Days 15, 29, 43, 57, 71, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 120 mg of the LAG3 inhibitor on Days 15, 29, 43, 57, 71, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 480 mg of the PD-1 inhibitor on Days 8, 36, 64, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg of the LAG3 inhibitor on Days 8, 36, 64, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 480 mg of the PD-1 inhibitor on Days 15, 43, 64, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 240 mg of the LAG3 inhibitor on Days 15, 43, 64, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 480 mg of the PD-1 inhibitor on Days 8, 36, 64, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 480 mg of the LAG3 inhibitor on Days 8, 36, 64, and 85.
1 more element
A method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering to the subject a PD-1 inhibitor in a dosing regimen comprising administration of 480 mg of the PD-1 inhibitor on Days 15, 43, 64, and 85;
- and
- (3) administering to the subject a LAG3 inhibitor in a dosing regimen comprising administration of 480 mg of the LAG3 inhibitor on Days 15, 43, 64, and 85.
1 more element
Use of a PD-1 inhibitor and a LAG3 inhibitor in the manufacture of a medicament for treating a subject having a CD19-expressing cancer, wherein the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1.
Use of a PD-1 inhibitor and a LAG3 inhibitor in the manufacture of a medicament for treating a subject having a CD19-expressing cancer, wherein the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1.
Use of a PD-1 inhibitor in the manufacture of a medicament for treating a subject having a CD19-expressing cancer, wherein:
- (1) at least two doses of the medicament are to be administered to the subject;
- (2) a first dose of the medicament is to be administered to the subject between Day 2 and Day 20, inclusive;
- (3) each dose of the medicament comprises between at or about 140 mg and at or about 580 mg of the PD-1 inhibitor, inclusive;
- and
- (4) the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1.
2 more elements
Use of a PD-1 inhibitor in the manufacture of a medicament for treating a subject having a CD19-expressing cancer, wherein:
- (1) at least two doses of the medicament are to be administered to the subject;
- (2) a first dose of the medicament is to be administered to the subject between Day 2 and Day 20, inclusive;
- (3) each dose of the medicament comprises between at or about 140 mg and at or about 580 mg of the PD-1 inhibitor, inclusive;
- and
- (4) the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1.
2 more elements
Use of a PD-1 inhibitor in the manufacture of a medicament for treating a CD19-expressing cancer, wherein:
- (1) at least two doses of the medicament are to be administered to the subject;
- (2) a first dose of the medicament is to be administered to the subject between Day 2 and Day 20, inclusive;
- (3) each subsequent dose of the medicament is to be administered about two weeks, about three weeks, or about four weeks after the previous dose of the medicament;
- and
- (4) the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1.
2 more elements
Use of a PD-1 inhibitor in the manufacture of a medicament for treating a CD19-expressing cancer, wherein:
- (1) at least two doses of the medicament are to be administered to the subject;
- (2) a first dose of the medicament is to be administered to the subject between Day 2 and Day 20, inclusive;
- (3) each subsequent dose of the medicament is to be administered about two weeks, about three weeks, or about four weeks after the previous dose of the medicament;
- and
- (4) the subject was previously administered a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1.
2 more elements
A combination of a PD-1 inhibitor and a LAG3 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- (2) administering a PD-1 inhibitor to the subject;
- and
- (3) administering a LAG3 inhibitor to the subject.
1 more element
A combination of a PD-1 inhibitor and a LAG3 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- (2) administering a PD-1 inhibitor to the subject;
- and
- (3) administering a LAG3 inhibitor to the subject.
1 more element
A PD-1 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each dose of the PD-1 inhibitor is between at or about 140 mg and at or about 580 mg, inclusive.
3 more elements
A PD-1 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) administration of a first dose of the PD-1 inhibitor is between Day 2 and Day 20, inclusive;
- and
- (ii) each dose of the PD-1 inhibitor is between at or about 140 mg and at or about 580 mg, inclusive.
3 more elements
A PD-1 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) that binds cluster of differentiation 19 (CD19) on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) a first dose of the PD-1 inhibitor is administered between Day 2 and Day 20, inclusive;
- and
- (ii) each subsequent dose of the PD-1 inhibitor is administered about two weeks, about three weeks, or about four weeks after the previous dose of the PD-1 inhibitor.
3 more elements
A PD-1 inhibitor for use in a method of treating a cancer, the method comprising:
- (1) administering to a subject having a CD19-expressing cancer a cell therapy comprising a dose of engineered cells comprising T cells expressing a chimeric antigen receptor (CAR) directed against the cancer on Day 1;
- and
- (2) administering a PD-1 inhibitor to the subject in a dosing regimen comprising administration of at least two doses, wherein:
- (i) a first dose of the PD-1 inhibitor is administered between Day 2 and Day 20, inclusive;
- and
- (ii) each subsequent dose of the PD-1 inhibitor is administered about two weeks, about three weeks, or about four weeks after the previous dose of the PD-1 inhibitor.
3 more elements
Dependencies are inferred from the claim text.