ACR Convergence 2025: Rheumatoid Arthritis Clinical Trial Insights

The phase 1 trial Regulate-RA exploring SBT777101 described early signals of clinical benefit: rapid reductions in swollen and tender joint counts and decreases in DAS28-CRP. The signal supports continued evaluation of CAR-Treg approaches in carefully selected refractory patients.

The open-label, single-arm phase 1 study treated six patients with an autologous CAR-Treg product and used joint counts and DAS28-CRP as clinical endpoints. To date, safety reporting identified no cytokine release syndrome, neurotoxicity, or dose-limiting toxicities; an efficacy signal appeared by week 4 and was described as persisting to week 18. Overall, this remains a small, interim data set that warrants validation in larger cohorts.

Integration of transcriptomic, proteomic, and cellular profiling improved prediction of early responders, adding discriminatory power beyond clinical measures alone. Such predictive models could help triage candidates for cell-therapy trials or prioritize monitoring resources in later-phase studies.