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

January 8, 2026 updated by: Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
        • Contact:
          • Cheng Wang, PhD
          • Phone Number: 027 85726808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cizutamig
Drug: Cizutamig
Cizutamig will be administered per the dose escalation cohort
Biological: Cizutamig
Cizutamig will be administered per the dose escalation cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in ECG parameters through end of study: QRS interval
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time Frame: Baseline to Month12
Baseline to Month12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time Frame: Baseline to Month 12
Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Time Frame: Baseline to Month 12
Baseline to Month 12
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.
Baseline to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetic (PK) for Cizutamig: Cmax
Time Frame: Baseline to Month 12
Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Time Frame: Baseline to Month 12
Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Time Frame: Baseline to Month 12
Baseline to Month 12
PK parameters for Cizutamig: clearance
Time Frame: Baseline to Month 12
Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Time Frame: Baseline to Month 12
Baseline to Month 12
PK parameters for Cizutamig: half-life
Time Frame: Baseline to Month 12
Baseline to Month 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamics of cizutamig
Time Frame: Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 8, 12, 16, 24, 36, 52)
Changes from baseline in CD19+ B cells counts
Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 8, 12, 16, 24, 36, 52)
Pharmacodynamics of cizutamig
Time Frame: Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 52)
Changes from baseline in inflammatory cytokines
Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 52)
Pharmacodynamics of cizutamig
Time Frame: Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 52)
Changes from baseline in soluble BCMA
Baseline to Month 12 (Screening, Day1, Day 8, 15, 22, 29, 36, Week 52)
Immunogenicity of cizutamig
Time Frame: Baseline to Month 12 (Day1, Day 8, 15, 22, 29, 36, Week 8, 12, 16, 24, 52)
Proportion of patients with ADAs before and after treatment
Baseline to Month 12 (Day1, Day 8, 15, 22, 29, 36, Week 8, 12, 16, 24, 52)
Patient-reported outcomes
Time Frame: Baseline to Month 12 (Screening, Day1, Day 8, 15, 29, Week 8, 12, 16, 24, 36, 52)
Change from baseline through Week 52 in HAQ-DI. Range [0, 3]，higher score represents more severe disability.
Baseline to Month 12 (Screening, Day1, Day 8, 15, 29, Week 8, 12, 16, 24, 36, 52)
Effect on affected tissues
Time Frame: From the baseline to Month 12 (Screening and Day 29)
Changes from baseline in cellular composition. Lymph node biopsy or Bone marrow biopsy.
From the baseline to Month 12 (Screening and Day 29)
Clinical activity of cizutamig
Time Frame: Baseline to Month 12 (Screening, Day1, Day 8, 15, 29, Week 8, 12, 16, 24, 36, 52)
Change from baseline in DAS28-hsCRP, higher score represents worse disease activity
Baseline to Month 12 (Screening, Day1, Day 8, 15, 29, Week 8, 12, 16, 24, 36, 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qiubai Li, Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UHCT250171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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