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

NCT06946199 | Recruiting Phase 1 DMC

• 1 other identifier: UHCT250171
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

cizutamig; rheumatoid arthritis

Outcome Measures

Primary Outcomes (11)

• Incidence and severity of treatment-emergent adverse events through end of study

  Incidence and severity of TEAEs through end of study.

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: body temperature

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: heart rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: respiratory rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: blood pressure

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: pulse oximetry

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: PR interval

  Baseline to Month12

• Changes from baseline in ECG parameters through end of study: QRS interval

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: QTcF interval

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: serum chemistry

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: hematology

  Baseline to Month 12

Secondary Outcomes (6)

• Pharmacokinetic (PK) for Cizutamig: Cmax

  Baseline to Month 12

• PK parameters for Cizutamig: time of maximum concentration

  Baseline to Month 12

• PK parameters for Cizutamig: area under the concentration-time curve

  Baseline to Month 12

• PK parameters for Cizutamig: clearance

  Baseline to Month 12

• PK parameters for Cizutamig: volume of distribution

  Baseline to Month 12

Study Arms (1)

Cizutamig

EXPERIMENTAL

Drug: Cizutamig; Biological: Cizutamig

Interventions

Cizutamig DRUG

Cizutamig will be administered per the dose escalation cohort

Cizutamig

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Qiubai Li, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808; qiubaili@hust.edu.cn

Di Wu

CONTACT

18790696175; 373181302@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 27, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)