T-cell engager programs are advancing toward the clinic, but developers face an important challenge in demonstrating efficacy and safety in a therapeutic class where traditional preclinical models often fail to predict human responses. Unlike oncology, where tumor killing can be readily measured, autoimmune TCEs must balance selective immune-cell depletion, cytokine control, and long-term disease modification in heterogeneous patient populations. This workshop will explore innovative approaches to generating more predictive translational data and overcoming bottlenecks in both preclinical and clinical development by:

• Advancing ex vivo and human-derived testing platforms to improve clinical predictability, exploring the use of patient-derived samples, diseased tissue models, organoid systems, and immune-cell co-culture assays to evaluate pharmacodynamic activity in settings that better reflect autoimmune biology
• Establishing translational frameworks for assessing efficacy and safety before firstin-human studies, examining which biomarkers, functional assays, and immunemonitoring approaches are most predictive of clinical outcomes
• Innovating patient recruitment and trial design for emerging autoimmune TCE programs, exploring approaches to identify appropriate patient subsets, leverage biomarker-driven enrolment strategies, and recruit patients with specific immunecell signatures most likely to benefit from targeted depletion therapies