As T-Cell Engager developers look beyond oncology into the complex landscape of autoimmune

disease, the rules of safety, dosing, and trial design change dramatically. This interactive workshop

will equip you with the critical clinical, translational, and regulatory insights needed to navigate these uncharted waters. Learn how to optimise dosing and prophylaxis to minimize CRS and neurotoxicity, manage the unique risks of B cell targeting and T cell activation in dysregulated immune systems, and adapt your molecule design and trial strategy for success across indications. If you’re planning to bring your TCE program into autoimmune disease, this is the must-attend strategy session to future-proof your clinical development pathway.

This workshop will cover:

• Key lessons from clinical T-Cell Engager trials – recurring safety, efficacy, and translational challenges, and how to proactively address data gaps to improve later-stage success
• Optimising dosing and prophylaxis – strategies to mitigate CRS, neurotoxicity, and other immune related toxicities, with comparison of tolerability thresholds between oncology and autoimmune disease settings
• Oncology vs. autoimmune disease differences – impact of B cell targeting and T cell activation dynamics, including risks of stimulating hypoactive or hyper-excitable T cells in autoimmune patients
• Translational and regulatory considerations for FIH studies – integrating preclinical insights, model limitations, and risk mitigation strategies to meet safety and regulatory requirements
• Tailoring molecular and trial design across indications – adapting formats, mechanisms, and study designs for oncology versus autoimmune disease, and best practices for engaging regulators on cross-indication programs