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(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07041099
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