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

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(2)

Cullinan Investigative Site

Erlangen, Germany

Cullinan Investigative Site

Rome, Italy

View Full Details on ClinicalTrials.gov

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NCT06994143