Phase I Study of CLN-978 Injected Under the Skin in Adults With Rheumatoid Arthritis Not Responding to Treatment

What this Trial Is About

Researchers are evaluating CLN-978, a CD19-directed T cell engager given by subcutaneous injection, in adults with rheumatoid arthritis RA that has not responded to other treatments. This Phase I, open-label study focuses on patients whose RA is driven by B cells and who have active disease despite trying at least two different targeted therapies. The trial aims to assess the safety and effects of CLN-978 in this treatment-refractory group. Participants will receive CLN-978 in two parts an initial dose escalation phase to find appropriate dosing, followed by further evaluation at selected doses. The drug will be given on specified days, and patients will be monitored throughout the study. There is no placebo group, and the study is open-label, meaning both researchers and participants know the treatment given. During the study, participants will have laboratory tests to monitor blood counts, kidney and liver function, and immune response markers. Researchers will track adverse events for up to 48 weeks and measure drug levels and anti-drug antibodies for 12 weeks. Disease activity and other biomarkers related to treatment effects will also be assessed. The total study duration includes screening and treatment phases extending up to nearly one year.

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis