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

NCT ID: NCT06946199

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2027-06-30

Brief 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.

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cizutamig

Group Type: EXPERIMENTAL

Cizutamig

Intervention Type: DRUG

Cizutamig will be administered per the dose escalation cohort

Cizutamig

Intervention Type: BIOLOGICAL

Cizutamig will be administered per the dose escalation cohort

Interventions

Cizutamig

Cizutamig will be administered per the dose escalation cohort

Intervention Type: DRUG

Cizutamig

Cizutamig will be administered per the dose escalation cohort

Intervention Type: BIOLOGICAL

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Qiubai Li

Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiubai Li, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiubai Li, Professor

Role: CONTACT

qiubaili@hust.edu.cn

85726808 ext. 027

Di Wu

Role: CONTACT

373181302@qq.com

18790696175 ext. 86

Facility Contacts

Qiubai Li, Professor

Role: primary

qiubaili@hust.edu.cn

85726808 ext. 027

Cheng Wang, PhD

Role: backup

85726808 ext. 027

Other Identifiers

UHCT250171

Identifier Type: -

Identifier Source: org_study_id