NCT06946199RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 23 Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06946199
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 28
- From 23 Jun 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 18 to 75 years old at the time of signing the informed consent form
- Diagnosis of adult-onset RA as defined by the 2010 ACR/EULAR classification criteria
- Moderately to severely active RA.
- 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:
- Inadequate clinical laboratory parameters at Screening
- Patients with active infection
- Receipt of live vaccine within 4 weeks prior to Screening
- Presence of any concomitant autoimmune disease
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or a hereditary deficiency of the complement system
- Central nervous system disease
- Presence of 1 or more significant concurrent medical conditions per investigator judgment
- Have a diagnosis or history of malignant disease within 5 years
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.