Methods and compositions for treating autoimmune diseases
AssigneeCabaletta Bio, Inc.
InventorsGwendolyn Knowlton Binder, David Jihoon Chang Jihoon Chang, Samik Basu, Steven Alan Nichtberger
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Abstract
The invention relates generally to methods of treating autoimmune disease with immune cell therapy. The invention also relates generally to methods of treating autoimmune disease, comprising administering a preconditioning regimen with cyclophosphamide, and subsequently administering an immune cell therapy.
Claims81
A method of treating an autoimmune disease in a subject in need thereof, the method comprising:
- (a) administering to the subject a preconditioning regimen consisting essentially of one or more doses of 100-1,500 mg/m2/day cyclophosphamide;
- and
- (b) administering to the subject a therapeutically effective amount of engineered CAR immune cells,
- wherein the subject receives the cyclophosphamide no less than three days prior to step (b).
A method of treating an autoimmune disease in a subject in need thereof, the method comprising:
- (a) administering to the subject a preconditioning regimen comprising one or more doses of 100-800 mg/m2/day cyclophosphamide;
- and
- (b) administering to the subject a therapeutically effective amount of engineered CAR immune cells,
- wherein the preconditioning regimen comprises administering a total dose of cyclophosphamide of less than 1,000 mg/m2 to the subject.
A method of treating an autoimmune disease in a subject in need thereof, the method comprising:
- (a) administering to the subject a preconditioning regimen comprising one or more doses of 100-1,500 mg/m2/day cyclophosphamide;
- and
- (b) administering to the subject a therapeutically effective amount of engineered CAR immune cells,
- wherein the engineered CAR immune cells comprise a nucleic acid encoding a CAR, wherein the CAR comprises an extracellular antigen binding site comprising a heavy chain variable domain (VH) comprising complementarity determining regions CDRH1, CDRH2, and CDRH3 and a light chain variable domain (VL) comprising complementarity determining regions CDRL1, CDRL2, and CDRL3, wherein the CDRH1, CDRH2, and CDRH3 comprise the amino acid sequences of SEQ ID NOs:
- 1, 2, and 3, respectively, and the CDRL1, CDRL2, and CDRL3 comprise the amino acid sequences of SEQ ID NOs:
- 5, 6, and 7, respectively.
A method of treating an autoimmune disease in a subject in need thereof, wherein the method comprises administering an engineered immune cell comprising a nucleic acid encoding a CAR, wherein the CAR comprises:
- (i) an extracellular domain comprising an antigen binding site that binds CD19;
- (ii) a transmembrane domain;
- (iii) a costimulatory domain;
- and
- (iv) an intracellular signaling domain;
- wherein the antigen binding site comprises a heavy chain variable domain (VH) comprising complementarity determining regions CDRH1, CDRH2, and CDRH3 and a light chain variable domain (VL) comprising complementarity determining regions CDRL1, CDRL2, and CDRL3, wherein the CDRH1, CDRH2, and CDRH3 comprise the amino acid sequences of SEQ ID NOs:
- 1, 2, and 3, respectively, and the CDRL1, CDRL2, and CDRL3 comprise the amino acid sequences of SEQ ID NOs:
- 5, 6, and 7, respectively.
Dependencies are inferred from the claim text.