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US 12,510,548 B2Granted
Method of determining toxicity of an immunomodulatory drug for use in humans
AssigneeThe Jackson Laboratory
InventorsJames Keck, Chunting Ye
Life of this patent
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Abstract
Humanized mouse models and methods are provided for determining whether administration of an immunomodulatory drug likely elicits a severe cytokine release syndrome in a human. Humanized mouse models and methods are also provided for determining the immunotoxicity in a human of a drug candidate or of drug combinations.
Claims20
A method for assessing immune toxicity of an immunomodulatory agent on a human immune system, the method comprising:
- (a) administering an immunomodulatory agent to an immunodeficient mouse that has been subjected to myeloablation and engrafted with human peripheral blood mononuclear cells (PBMCs);
- (b) measuring blood concentration of a human inflammatory cytokine in a sample from the immunodeficient mouse before the immunodeficient mouse develops a symptom of graft versus host disease (GVHD), wherein the blood concentration of the human inflammatory cytokine, relative to a threshold value, is indicative of severity of cytokine release;
- and
- (c) assessing immune toxicity of the immunomodulatory agent on the human immune system based on the severity of cytokine release.
1 more element
A method for assessing immune toxicity of an immunomodulatory agent on a human immune system, the method comprising:
- (a) administering an immunomodulatory agent to an irradiated immunodeficient mouse engrafted with human peripheral blood mononuclear cells (PBMCs);
- (b) measuring blood concentration of a human inflammatory cytokine in a sample from the immunodeficient mouse before the immunodeficient mouse develops a symptom of graft versus host disease (GVHD), wherein the blood concentration of the human inflammatory cytokine, relative to a threshold value, is indicative of severity of cytokine release;
- and
- (c) assessing immune toxicity of the immunomodulatory agent on the human immune system based on the severity of cytokine release.
1 more element
Dependencies are inferred from the claim text.