Presentation: Adverse Immune Stimulation in Clinical Trials

This presentation explores the growing challenge of adverse immune stimulation (AIS) in early-phase clinical trials as drug development increasingly shifts toward complex therapeutics such as biologics and therapeutic proteins. Drawing on recent experiences at the Centre for Human Drug Research, it highlights both the clinical presentation and mechanistic basis of AIS, including lessons learned from recent clinical cases. The talk will discuss which classes of compounds warrant increased vigilance for AIS, the potential causes and mechanisms underlying immune activation, and how standardized monitoring of adverse immune stimulation biomarkers can support early recognition, mechanistic interpretation, and clinical management. By integrating biomarker-driven blood sampling, IMP-specific mitigation strategies, and translational immune monitoring, these approaches aim to enhance the scientific value of early clinical programs while supporting safe and informed trial continuation.