Cizutamig: Cizutamig will be administered per the dose escalation cohort
Cizutamig: Cizutamig will be administered per the dose escalation cohort
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence and severity of treatment-emergent adverse events through end of study — Baseline to Month 12 Incidence and severity of TEAEs through end of study.
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
Trial sites (1)
Facility
City
Region
Status
Wuhan Union Hospital
Wuhan
Hubei
Recruiting
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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