Rheumatoid Arthritis (RA)Phase 1NCT06946199
An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis
A Phase 1 study testing Cizutamig in people with Rheumatoid Arthritis (RA), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Cizutamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Qiubai Li, Professor, 85726808 ext. 027, qiubaili@hust.edu.cn
Cheng Wang, PhD, 85726808 ext. 027
About this study
Official title: An Open-label Study Evaluating the Safety and Preliminary Clinical Activity of Cizutamig in Patients With Refractory Seropositive Rheumatoid Arthritis
The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.
Read the detailed description
B cells mature into plasmablasts and plasma cells that are prolific antibody producers and the predominant source of pathogenic autoantibodies, a hallmark of RA. Autoantibodies contribute to the pathogenesis of RA in several ways, including formation of immune complexes, activation of complement and downstream cell lysis. Clinical trials of cizutamig (BCMAxCD3 T-cell engager) demonstrated safety and efficacy in RRMM. Cizutamig offers a promising mechanism of action for refractory seropositive RA. This study aims to assess the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig administered in patients with refractory seropositive RA. Patients will be invited to participate in the study, to receive cizutamig and monitored after dosing with cizutamig through Week 52.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Cizutamig
- Keywords
- cizutamig, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CizutamigDrug
Cizutamig will be administered per the dose escalation cohort
CizutamigBiological
Cizutamig will be administered per the dose escalation cohort
| Study group | Role | What they receive |
|---|---|---|
| Cizutamig | Experimental | Not described Receives: Drug: Cizutamig; Biological: Cizutamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events through end of study
Incidence and severity of TEAEs through end of study.
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Measured: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QRS interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Measured: Baseline to Month 12
Secondary outcomes (6)
Pharmacokinetic (PK) for Cizutamig: Cmax
Measured: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Measured: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Measured: Baseline to Month 12
PK parameters for Cizutamig: clearance
Measured: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Measured: Baseline to Month 12
PK parameters for Cizutamig: half-life
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start23 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946199
- Sponsor's protocol ID
- UHCT250171
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Evaluating the Safety and Preliminary Clinical Activity of Cizutamig in Patients With Refractory Seropositive Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06946199
- Acronym / sponsor ID
- UHCT250171
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- cizutamig, rheumatoid arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.
Detailed description
B cells mature into plasmablasts and plasma cells that are prolific antibody producers and the predominant source of pathogenic autoantibodies, a hallmark of RA. Autoantibodies contribute to the pathogenesis of RA in several ways, including formation of immune complexes, activation of complement and downstream cell lysis. Clinical trials of cizutamig (BCMAxCD3 T-cell engager) demonstrated safety and efficacy in RRMM. Cizutamig offers a promising mechanism of action for refractory seropositive RA. This study aims to assess the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig administered in patients with refractory seropositive RA. Patients will be invited to participate in the study, to receive cizutamig and monitored after dosing with cizutamig through Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cizutamig | Experimental | Drug: Cizutamig, Biological: Cizutamig |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CizutamigCizutamig will be administered per the dose escalation cohort | Drug | Cizutamig |
| CizutamigCizutamig will be administered per the dose escalation cohort | Biological | Cizutamig |
Primary outcome
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Month 12
Incidence and severity of TEAEs through end of study.
Changes from baseline in vital signs through end of study: body temperature
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Time frame: Baseline to Month 12
6 secondary outcomes
Pharmacokinetic (PK) for Cizutamig: Cmax
Time frame: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for Cizutamig: clearance
Time frame: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Time frame: Baseline to Month 12
PK parameters for Cizutamig: half-life
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiubai Li, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cizutamig in people with Rheumatoid Arthritis (RA), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiubai Li, Professor (85726808 ext. 027, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events through end of study (time frame: Baseline to Month 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.