Status:
NOT_YET_RECRUITING
A Study of Cizutamig in Systemic Sclerosis
Lead Sponsor:
Ruijin Hospital
Conditions:
Systemic Sclerosis (SSc)
Eligibility:
All Genders
18-75 years
Phase:
EARLY_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 SSc.
Detailed Description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
Eligibility Criteria
Inclusion
- ICriteria:
- 18 to 75 years old at the time of signing the informed consent form (ICF)
- Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria
- Diffuse cutaneous SSc according to the LeRoy criteria
- Positive for at least 1 SSc-specific parameter as specified in the protocol
- Disease duration of ≤ 7 years
- mRSS ≥ 15
- Inadequate response to therapies defined in the protocol.
Exclusion
- Inadequate clinical laboratory parameters at Screening
- Receipt of or inability to discontinue any excluded therapies as specified in the protocol
- Receipt of live vaccine within 4 weeks prior to Screening
- Presence of any concomitant autoimmune disease other than the disease being studied
- Receiving or anticipated to require total parenteral nutrition during the study
- Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth
- Active or history of gastric antral vascular ectasia
- Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study
- Active or history of scleroderma renal crisis
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or a hereditary deficiency of the complement system
- Central nervous system (CNS) disease
- Have presence of 1 or more significant concurrent medical conditions per investigator judgment
- Have a diagnosis or history of malignant disease within 5 years prior to Screening
- Inability to comply with contraception requirements as specified in the protocol
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07158996
Start Date
September 4 2025
End Date
August 31 2027
Last Update
September 8 2025
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