Biomarkers related to immunotherapy efficacy
AssigneeKite Pharma, Inc.
InventorsSoumya Poddar, Gabriela Balderrama-Gutierrez, Davide Bedognetti, Michael D. Mattie
Life of this patent
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Abstract
The disclosure relates to methods for predicting a likelihood of a relapse to a cancer in a patient following treatment of the patient with an immunotherapy product, and methods for improving efficacy of an immunotherapy product for a patient with a likelihood of a relapse to a cancer following treatment with an immunotherapy product.
Claims44
A method for manufacturing transformed lymphocytes, comprising:
- measuring an expression level of GATA3 in a sample of lymphocytes collected from a subject;
- reducing an activity of or an amount of GATA3+ CD8+ cells from the sample of lymphocytes if the expression level of GATA3 in the sample of lymphocytes is above a control value;
- and
- incubating the sample of lymphocytes with a polynucleotide vector to transform the sample of lymphocytes to produce transformed lymphocytes.
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A method of predicting a likelihood of a relapse to a cancer in a patient treated with a cell therapy product comprising:
- measuring a pre-treatment level of GATA3+CD8+ cells in a sample of lymphocytes collected from the subject pre-treatment;
- determining the likelihood of relapse in the patient from the pre-treatment level of GATA3+CD8+ cells,
- wherein an elevated pre-treatment level of GATA3+CD8+ cells as compared to a pre-treatment control value from patients with the same cancer and same prior lines of therapy, if any, is indicative of an increased likelihood of relapse in the patient, and
- wherein the patient is treated with the cell therapy product after the measuring the pre-treatment level of GATA3+CD8+ cells.
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A method of predicting a likelihood of a relapse to a cancer in a patient treated with a cell therapy product comprising:
- measuring a pre-treatment Th1-Th2 index in a sample of lymphocytes collected from the subject pre-treatment;
- determining the likelihood of relapse in the patient from the pre-treatment Th1-Th2 index,
- wherein a pre-treatment Th1-Th2 index below 0.0 is indicative of an increased likelihood of relapse in the patient, and
- wherein the patient is treated with the cell therapy product after the measuring the pre-treatment Th1-Th2 index.
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A method for treating a malignancy in a patient comprising:
- measuring an expression level of GATA3 in a cell therapy product;
- determining whether the patient should be administered an effective dose of the cell therapy product, or an effective dose of the cell therapy product and an inhibitor of a Th2 cytokine based on the measuring the expression level of GATA3;
- and
- administering the effective dose of the cell therapy product, or the effective dose of the cell therapy product and the inhibitor of a Th2 cytokine based on the determining step,
- wherein the patient is administered the effective dose of the cell therapy product if the expression level of GATA3 is at or below a control value, and wherein the patient is administered the effective dose of the cell therapy product and the inhibitor of a Th2 cytokine if the expression level of GATA3 is above the control value.
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Dependencies are inferred from the claim text.