Status:
NOT_YET_RECRUITING
An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 patho...
Eligibility Criteria
Inclusion
- 18 to 75 years old at the time of signing the informed consent form (ICF)
- Diagnosis of adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 3 months prior to Screening.
- Class I-III RA
- 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 at least 1 tsDMARD and/or bDMARD after 12 weeks of treatment duration
- Stable use of any of the background therapy (alone or in combination) up to Day 1
Exclusion
- Inadequate clinical laboratory parameters at Screening
- Patients with active infection
- Receipt of or inability to discontinue any excluded therapies
- Receipt of live vaccine within 4 weeks prior to Screening
- Presence of any concomitant autoimmune disease
- Active or known history of catastrophic anti-phospholipid syndrome (APS)
- APS or thrombotic event not adequately controlled by anticoagulation therapy
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or a hereditary deficiency of the complement system
- Central nervous system (CNS) 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
- Inability to comply with protocol-mandated requirements
- History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug.
- Intolerability to required prophylactic anti-infective medications .
- History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation for the duration of the study.
- Major surgery requiring use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period (from Screening to patient's last visit).
- Any serious medical condition or abnormality on clinical laboratory testing
- Women who are pregnant or breastfeeding.
- Sexually active male patients who do not agree to refrain from donating semen
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06946199
Start Date
June 1 2025
End Date
November 30 2026
Last Update
April 27 2025
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000