CLN-978-SL-101: A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE).

The Purpose of the Study
Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the body’s immune system attacks its own healthy tissues. This study evaluates an investigational drug called CLN-978 to see if it is safe and effective at reducing disease activity by targeting and “resetting” the immune cells (B cells) responsible for the inflammation found in Lupus.

What is CLN-978?
CLN-978 is a “T-cell engager.” It is designed to bring your body’s T cells (powerful immune cells) into contact with B cells that carry a specific marker (CD19). By doing this, CLN-978 helps the immune system eliminate the problematic B cells that drive Lupus symptoms. Unlike many current treatments, this drug is administered as a subcutaneous injection (under the skin).

Who Can Participate?
You may be eligible to participate if you:

Are between 18 and 70 years old.

Have a confirmed diagnosis of Moderate to Severe SLE.

Have tried at least two standard Lupus treatments (e.g., steroids, antimalarials, or biologics) and found they did not provide enough relief.

Meet specific laboratory requirements (such as positive tests for ANA or anti-dsDNA antibodies).

What to Expect During the Trial
Study Design: This is an “open-label” study, meaning every participant receives the investigational drug (there is no placebo).

Dosing: The drug is given by injection. Some participants may receive a single dose, while others may receive multiple doses, depending on the stage of the study.

Monitoring: Safety is the top priority. Participants will be monitored closely by a medical team. This includes a brief inpatient hospital stay for initial doses to monitor for common side effects like Cytokine Release Syndrome (CRS).

Duration: Total participation lasts up to approximately 25 months, which includes a screening period, the treatment phase, and a long-term follow-up period to monitor your health.

Why Participate?
By participating, you will be contributing to the development of potential new therapies for SLE. While there is no guarantee of direct health benefits, the data collected will help researchers understand if CLN-978 can provide a long-lasting “immune reset” for those living with severe Lupus.