Michael Liao

As the first generation of autoimmune T-cell engagers advances through clinical development, the field is beginning to generate critical insights into safety management, depth of immune-cell depletion, patient selection, and long-term disease control. The key challenge now is determining which clinical learnings will truly differentiate successful therapies. Join clinical leaders, translational scientists, and developers of leading autoimmune T-cell engager programs as they discuss how emerging clinical evidence is reshaping drug design and development strategies by:

• Defining the clinical benchmarks for success, evaluating what early efficacy, safety, cytokine release syndrome, and durability data reveal about the therapeutic potential of T-cell engagers across different autoimmune diseases and patient populations
• Understanding the drivers of durable immune reset, exploring how depth of depletion and target biology, contribute to longterm remission, and identifying the biomarkers needed to predict sustained clinical benefit
• Translating clinical learnings into next-generation molecule design, discussing how insights from first-wave programs are informing improvements in target selection, construct engineering, dosing strategies, administration routes, and patient monitoring to enhance efficacy while minimizing treatment burden and safety risks

• Evaluating how clinical pharmacology insights from advanced CD3 bispecific programs can inform first-in-human study design, dose escalation strategies, cytokine release syndrome mitigation, and therapeutic window optimization in autoimmune disease settings
• Integrating pharmacokinetic, pharmacodynamic, and biomarker-driven approaches to better predict immune-cell depletion, target engagement, and early efficacy signals, enabling more informed and efficient clinical development decisions
• Leveraging translational and early human data from late-stage T-cell engager programs to refine patient selection, dosing paradigms, and safety monitoring frameworks that support accelerated development and improved patient outcomes