Study of mRNA Therapy ABO2203 for Safety and Early Effectiveness in Adults with Hard-to-Treat Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an mRNA drug called ABO2203, which encodes a CD19CD3 T cell engager, in patients with autoimmune diseases that have not responded well or have relapsed after standard treatments. This early phase 1 study focuses on patients with refractory autoimmune diseases who have shown inadequate response to standard care or have relapsed. The study involves administering ABO2203 injection as the investigational treatment. It includes a dose escalation phase to determine appropriate dosing and a dose expansion phase to further assess safety and preliminary efficacy. Participants will receive the study drug under medical supervision, with close monitoring throughout the treatment period. Participants will be observed from the first dose of the study treatment up to 30 days after the last dose for any treatment-emergent adverse events, including serious events and those causing interruption or early termination of treatment. The research team will carefully monitor these safety outcomes while also assessing how the drug behaves in the body. The study is expected to continue until December 2028, and participants will be involved during the treatment and follow-up periods as scheduled by the research team.

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases