Patent ID: 11959925
Assignee: THE JACKSON LABORATORY
Field: Measurement (Instruments)
Classification: CPC G  A  C | IPC A  C  G

Claim 0:
1. A method for assessing immune toxicity of an immunomodulatory agent on a human immune system, the method comprising:
(a) subjecting an immunodeficient mouse to myeloablation;
(b) administering 1.5×107-3.0×107 human peripheral blood mononuclear cells (PBMCs) to the immunodeficient mouse;
(c) administering an immunomodulatory agent to the immunodeficient mouse fewer than 8 days after the administering of the human PBMCs;
(d) measuring blood concentration of a human cytokine selected from interferon-gamma (IFN-γ), interleukin (IL)-10, IL-6, IL-2, IL-4, and tumor necrosis factor alpha (TNFα) in a sample from the immunodeficient mouse, within 24 hours of the administering of the immunomodulatory agent,
(e) determining severity of cytokine release induced by the immunomodulatory agent based on a comparison of the blood concentration of the human cytokine to a threshold value; and
(f) assessing immune toxicity of the immunomodulatory agent on the human immune system based on the severity of cytokine release.