Phase 1b Open-Label Study of CLN-978 Given by Injection for Adults with Active Moderate to Severe Sjogrens Disease

What this Trial Is About

Researchers are evaluating CLN-978, a CD19-directed T cell engager given by subcutaneous injection, in adults with active, moderate to severe Sjogrens Disease. This phase 1b, open-label study aims to assess the safety and tolerability of CLN-978 over 48 weeks in patients who meet specific disease criteria and laboratory parameters. Participants receive CLN-978 in two parts an initial dose escalation phase to find the appropriate dose, followed by further dose evaluation. The treatment is delivered subcutaneously at specified doses on specified days, monitored closely for safety and immune response. During the study, participants undergo regular assessments including blood tests to measure drug levels, immune cell changes, and anti-drug antibodies. Safety monitoring continues throughout the 48-week period, with researchers tracking disease activity and any adverse effects. The total study duration extends until March 2029, allowing long-term evaluation of treatment impact.

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease