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BIOMARKERS PREDICTIVE OF CYTOKINE RELEASE SYNDROME

  • US 20180252727A1
  • Filed: 09/02/2016
  • Published: 09/06/2018
  • Est. Priority Date: 09/03/2015
  • Status: Active Grant
First Claim
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1. A method of evaluating, e.g., predicting, a subject'"'"'s risk of developing cytokine release syndrome (CRS), e.g., severe CRS, comprising:

  • acquiring a CRS risk status for the subject, e.g., in response to a CAR-expressing cell therapy (e.g., a CAR19-expressing cell therapy), wherein said CRS risk status comprises a measure of one, two, three, four, five, six, seven, eight, nine, ten, or more (all) of the following;

    (i) the level or activity of soluble gp130 (sgp130) or interferon-gamma (IFN-g), or a combination thereof, in the subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is an adult or pediatric subject;

    (ii) the level or activity of sgp130, IFN-gamma, or IL1Ra, or a combination thereof (e.g., a combination of any two or all three of sgp130, IFN-gamma, and IL1Ra), in the subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is an adult or pediatric subject;

    (iii) the level or activity of sgp130 or IFN-gamma or a combination thereof, in a sample (e.g., a blood sample), and the level of bone marrow disease in the subject, e.g., wherein the subject is a pediatric subject;

    (iv) the level or activity of sgp130, IFN-gamma, or MIP1-alpha, or a combination thereof (e.g., a combination of any two or all three of sgp130, IFN-gamma, and MIP1-alpha), in a sample (e.g., a blood sample), e.g., wherein the subject is a pediatric subject;

    (v) the level or activity of sgp130, MCP1, or eotaxin, or a combination thereof (e.g., a combination of any two or all three of sgp130, MCP1, or eotaxin), in the subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is an adult or a pediatric subject;

    (vi) the level or activity of IL2, eotaxin, or sgp130, or a combination thereof (e.g., a combination of any two or all three of IL2, eotaxin, or sgp130), in the subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is an adult or a pediatric subject;

    (vii) the level or activity of IFN-gamma, IL2, or eotaxin, or a combination thereof (e.g., a combination of any two or all three of IFN-gamma, IL2, or eotaxin), in the subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is a pediatric subject;

    (viii) the level or activity of IL10 and the level of disease burden in the subject, or a combination thereof in a subject, e.g., in a sample (e.g., a blood sample), e.g., wherein the subject is a pediatric subject;

    (ix) the level or activity of IFN-gamma or IL-13, or a combination thereof, in the subject, e.g., wherein the subject is a pediatric subject;

    (x) the level or activity of IFN-gamma, IL-13, or MIP1-alpha, or a combination thereof (e.g., a combination of any two or all three of IFN-gamma, IL-13, and MIP1-alpha), in a sample (e.g., a blood sample), e.g., wherein the subject is a pediatric subject;

    or(xi) the level or activity of IFN-gamma or MIP1-alpha, or a combination thereof, in a sample (e.g., a blood sample), e.g., wherein the subject is a pediatric subjectwherein the CRS risk status is indicative of the subject'"'"'s risk for developing CRS, e.g., severe CRS.

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