RecruitingPhase 1NCT06994143
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis
A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)
Sponsor
Cullinan Therapeutics Inc.
Enrollment
37 participants
Start Date
May 19, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new drug called CLN-978 — given by injection under the skin — in people with rheumatoid arthritis (RA) that hasn't responded to at least two different targeted treatments. CLN-978 is designed to deplete B cells, which are immune cells that drive joint inflammation in RA.
**You may be eligible if...**
- You have had a confirmed RA diagnosis for at least 12 weeks
- Your RA is still active (a disease activity score of 3.2 or higher, with at least one swollen joint)
- You have already tried and failed at least 2 different targeted RA therapies (including biologics or targeted synthetic DMARDs), after failing conventional DMARDs
- Your blood tests show sufficient levels of immune cells and organ function
**You may NOT be eligible if...**
- You have another active inflammatory disease (other than secondary Sjögren's or thyroiditis)
- You have a serious unstable medical condition unrelated to RA
- You have received certain prior treatments that the study team will specify
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(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06994143
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