Status:
RECRUITING
Clinical Study of Cizutamig in Systemic Lupus Erythematosus
Lead Sponsor:
Candid Therapeutics
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients wi...
Eligibility Criteria
Inclusion
- 18 to 75 years old at the time of signing the informed consent form
- Diagnosis of SLE according to the ACR/EULAR classification criteria
- Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening
- SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening
- The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening
- Stable use of concomitant therapies
- For patients with active LN only: LN Class III or IV
Exclusion
- Inadequate clinical laboratory parameters at Screening
- 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 disease
- Presence of 1 or more significant concurrent medical conditions
- 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 cizutamig
- History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
- Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
- Women who are pregnant or breastfeeding
- Patients who do not agree to the use of highly effective contraception as defined by the protocol
- Individuals considered to be part of a vulnerable population (eg, incarceration)
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT07215663
Start Date
September 4 2025
End Date
April 1 2028
Last Update
November 17 2025
Active Locations (1)
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1
Chinese Academy of Medical Sciences and Peking Union Medical College Hospital
Beijing, China