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Cell-mediated Immune Responses

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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

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Navigating adverse immunostimulation: A practical guide for clinical researchers.

Juliette A van den Noort^1,2, Anouk C Meijs^1,2, Naomi B Klarenbeek^1,2

¹Centre for Human Drug Research, Leiden, the Netherlands.

British Journal of Clinical Pharmacology

|September 13, 2025

Summary

Adverse immune stimulation (AIS) complicates drug development. Standardized biomarker analysis in early trials helps manage AIS, understand drug mechanisms, and improve clinical trial efficiency.

Keywords:

adverse drug reactions drug safety immunostimulation

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Area of Science:

Pharmacology
Clinical Trial Management
Immunotoxicology

Background:

Drug development faces challenges with complex products causing adverse immune stimulation (AIS).
Unwanted immune system activation can hinder early clinical development programs.

Purpose of the Study:

To introduce standardized procedures for managing AIS in early clinical trials.
To gain insights into the mechanism of action of investigational medicinal products (IMPs).
To improve decision-making processes in drug development.

Main Methods:

Implementing standardized blood sampling procedures.
Measuring specific biomarkers for AIS.
Systematic evaluation of AIS biomarkers throughout early phase clinical trials.

Main Results:

AIS can be managed effectively using standardized procedures.
Biomarker analysis provides insights into IMP mechanism of action.
Informed decisions regarding IMP re-exposure and pre-medication can be made.

Conclusions:

Systematic AIS biomarker evaluation enhances understanding of pathophysiological mechanisms.
Standardized AIS assessment leads to more efficient and informative clinical trials.
This approach can prevent premature discontinuation of promising drug candidates.