Chapter 133 : Monitoring of Immunologic Therapies

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Biologic therapies have gained considerable acceptance in recent years. A broad array of biologic agents have become available for the treatment of inheritable or acquired immunodeficiency, autoimmune diseases, cancer, or persistent infections. Biologic therapies can be categorized as follows: (i) monoclonal antibodies (MAbs), (ii) cytokines, (iii) growth factors, (iv) activated cells, (v) cellular products, (vi) immunotoxins, and (vii) other immunomodulatory agents. Ex vivo preclinical studies of the new agent with human mononuclear cells (MNC) are often helpful in providing a rationale for targeting therapy to a particular subset of these cells or for focusing mechanistic studies on a particular cell population. The rationale for monitoring immunologic parameters in clinical trials with biologic agents is based on the premise that these agents achieve therapeutic effects as a result of their ability to modify one or more components of the patient’s immune system. In clinical trials with cytokines, it is important to measure the pharmacokinetics of the cytokine used for therapy as well as the levels of secondary cytokines in serum, which might be responsible for toxicity of the therapy. Monitoring of immune functions generally requires considerable cell numbers, fairly large volumes of blood or other body fluids, and facilities to process these samples for cell recovery. Cryopreservation may introduce artifacts, even when a rate-controlled drop in temperature is implemented. A vast array of labeled MAbs suitable for multicolor and multiparameter flow analyses are commercially available, allowing the measurement of the proportions of various immune cell subsets.

Citation: Whiteside T. 2006. Monitoring of Immunologic Therapies, p 1171-1182. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch133

Key Concept Ranking

Phase III Clinical Trial
Phase I Clinical Trial
Tumor Necrosis Factor
Human immunodeficiency virus 1
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Immunologic assays currently available for monitoring of phase I clinical trails with biologic agents

Citation: Whiteside T. 2006. Monitoring of Immunologic Therapies, p 1171-1182. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch133

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