Actively Recruiting
Clinical Study of Cizutamig in Systemic Lupus Erythematosus
Led by Candid Therapeutics · Updated on 2025-11-17
47
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus
CONDITIONS
Official Title
Clinical Study of Cizutamig in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent signing
- Diagnosis of Systemic Lupus Erythematosus (SLE) per ACR/EULAR criteria
- Positive anti-dsDNA or anti-Smith antibodies plus positive ANA at screening
- SLEDAI-2K total score of 6 or higher and clinical score of 4 or lower at screening
- Inadequate response to prior treatment for at least 3 months before screening
- Stable use of concomitant therapies
- For active lupus nephritis patients only: Class III or IV lupus nephritis
You will not qualify if you...
- Inadequate clinical laboratory results at screening
- Active infection
- Use of or inability to stop excluded therapies
- Receipt of live vaccine within 4 weeks before screening
- Presence of other autoimmune diseases
- Active or history of catastrophic anti-phospholipid syndrome
- Uncontrolled anti-phospholipid syndrome or thrombotic event
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or hereditary complement deficiency
- Central nervous system disease
- Significant concurrent medical conditions
- Diagnosis or history of cancer within 5 years
- Serious mental illness, substance abuse, dementia, or inability to understand consent
- Inability to comply with study requirements
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapies or cizutamig components
- History or planned organ transplant or stem cell transplantation
- Major surgery with general anesthesia within 12 weeks or planned during study
- Pregnancy or breastfeeding
- Refusal to use highly effective contraception
- Being part of a vulnerable population such as incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences and Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
L
Liu Tian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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