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

Recruiting · NCT06946199 · Interventional (participants receive a specific treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Interventions studied

Cizutamig

The purpose of the study is to evaluate the safety and efficacy of BCMAxCD3 T-cell engager (cizutamig) in patients with refractory seropositive RA.

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1

Study type

Interventional (participants receive a specific treatment)

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

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

1 location listed.