Cizutamig for refractory seropositive rheumatoid arthritis
Official title: An Open-label Study Evaluating the Safety and Preliminary Clinical Activity of Cizutamig in Patients With Refractory Seropositive Rheumatoid Arthritis
Run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT06946199 · Data updated 2026-11-12
This trial tests whether cizutamig, a BCMAxCD3 T‑cell engager, is safe and can help adults with seropositive rheumatoid arthritis that has not responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT06946199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with adult‑onset, moderately to severely active seropositive RA (RF and/or ACPA positive) who have not responded to or tolerated tsDMARDs and/or bDMARDs are the intended participants.
✕Probably not a fit
Patients who are seronegative, have other concomitant autoimmune diseases, active infections, immunodeficiency, recent live vaccination, CNS disease, or recent malignancy are unlikely to be eligible or benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open‑label Phase 1 trial that gives cizutamig to adults with refractory seropositive rheumatoid arthritis and follows them for 52 weeks after dosing. The primary focus is safety and tolerability, with collection of pharmacokinetic, pharmacodynamic, and immunogenicity data. Investigators will also record preliminary clinical activity to see if symptoms or biomarkers improve. Eligible participants must have moderately to severely active RA and prior inadequate response or intolerance to targeted synthetic or biologic DMARDs.
Why it matters
Potential benefit: If successful, cizutamig could reduce disease‑causing antibody‑producing B cells and improve symptoms in patients with refractory seropositive RA.
How similar studies have gone: Cizutamig (BCMAxCD3) has shown safety and clinical activity in trials for relapsed/refractory multiple myeloma, but using a BCMA‑targeting T‑cell engager in seropositive RA is a novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 to 75 years old at the time of signing the informed consent form 2. Diagnosis of adult-onset RA as defined by the 2010 ACR/EULAR classification criteria 3. Moderately to severely active RA. 4. Positive test results for RF and/or ACPA at Screening. Inadequate treatment response defined as either lack of clinical benefit or intolerability to treatment with tsDMARD and/or bDMARD Exclusion Criteria: 1. Inadequate clinical laboratory parameters at Screening 2. Patients with active infection 3. Receipt of live vaccine within 4 weeks prior to Screening 4. Presence of any concomitant autoimmune disease 5. History of progressive multifocal leukoencephalopathy 6. History of primary immunodeficiency or a hereditary deficiency of the complement system 7. Central nervous system disease 8. Presence of 1 or more significant concurrent medical conditions per investigator judgment 9. Have a diagnosis or history of malignant disease within 5 years 10. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice
Where it's running
-
Wuhan Union Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Principal investigator: Qiubai Li, Professor — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Qiubai Li, Professor
- Email: qiubaili@hust.edu.cn
- Phone: 85726808
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Heart Rate Variability and Rheumatoid Arthritis: What HRV Looks Like with RA
This study checks whether continuous HRV data from an Oura ring can reflect RA disease activity in adults with RA.
-
Discontinuing MTX or LEF in RA Patients on TNF Inhibitors
This trial tests whether stopping methotrexate or leflunomide while continuing a TNF inhibitor is not worse for disease control in adults with rheumatoid arthritis.
-
FT839 therapy for autoimmune diseases
This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.
-
24-Hour Movement and Atherosclerotic Risk in adults with rheumatoid arthritis
This study tests how daily activity, sitting, and sleep relate to heart-related risk in adults with RA, using wearables and follow-up after a year.
-
Integrative AI profiling of chronic RA pain
This study tests whether an AI-driven multiomic and neurophysiological approach can help explain and predict persistent pain in adults with active rheumatoid arthritis.
-
Oxidative Stress and Heart Risk in People with Rheumatoid Arthritis
This study tests whether certain markers of oxidative stress in people with rheumatoid arthritis are linked to subclinical atherosclerosis and arterial stiffness, which could relate to future heart disease risk.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.