RecruitingPhase 1NCT06946199

An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis

An Open-label Study Evaluating the Safety and Preliminary Clinical Activity of Cizutamig in Patients With Refractory Seropositive Rheumatoid Arthritis


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

28 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called cizutamig for people with seropositive rheumatoid arthritis (RA) — a type of joint inflammation where certain antibodies are detected in the blood — whose disease hasn't been controlled by existing biologic or targeted synthetic medications. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rheumatoid arthritis and your blood tests are positive for RF or ACPA antibodies - Your RA is moderately to severely active - You have already tried and failed or couldn't tolerate at least one advanced RA medication (biologic or targeted synthetic DMARD) **You may NOT be eligible if...** - Your blood test results are outside the safe range for this study - You have an active infection - You received a live vaccine within the past 4 weeks - You have other serious conditions that could affect participation or safety 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

DRUGCizutamig

Cizutamig will be administered per the dose escalation cohort

BIOLOGICALCizutamig

Cizutamig will be administered per the dose escalation cohort


Locations(1)

Wuhan Union Hospital

Wuhan, Hubei, China

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NCT06946199


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