RecruitingPhase 1NCT07041099

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

A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease


Sponsor

Cullinan Therapeutics Inc.

Enrollment

36 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called CLN-978 — given as an injection under the skin — in people with Sjögren's disease (an autoimmune condition that causes dry eyes, dry mouth, and fatigue). CLN-978 is designed to target and reduce certain immune cells (B cells) that drive the disease. This is a first study in humans for this type of treatment approach. **You may be eligible if...** - You have been diagnosed with Sjögren's disease for at least 24 weeks - Your disease is moderately to severely active based on standard assessments - Your blood counts (white cells, B cells, platelets, hemoglobin) meet the required levels - Standard disease-modifying treatments have not worked well enough **You may NOT be eligible if...** - You have another serious autoimmune condition requiring active treatment - You have had certain infections (such as active tuberculosis or hepatitis B or C) - You have had a significant cancer diagnosis in recent years - You have severely abnormal liver or kidney function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCLN-978

Specified dose on specified days


Locations(14)

Omega Research

Orlando, Florida, United States

New York University

Brooklyn, New York, United States

Regional One

Memphis, Tennessee, United States

Stryde Research

Plano, Texas, United States

Tranquil Research

Webster, Texas, United States

Intermountain

Salt Lake City, Utah, United States

CHU Brest

Brest, France

Hopitaux Universitaires Paris-Sud

Le Kremlin-Bicêtre, France

CHU Nantes

Nantes, France

CHU St.-Étienne

Saint-Priest-en-Jarez, France

CHU Strasbourg-Hautepierre

Strasbourg, France

University Hospital Erlangen

Erlangen, Germany

Hannover Medical School

Hanover, Germany

Fondazione Policlinico Universitario A Gemelli

Roma, Italy

View Full Details on ClinicalTrials.gov

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NCT07041099


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