NCT07158996Not yet recruitingEarly phase 1
A Study of Cizutamig in Systemic Sclerosis
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with SSc.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 4 Sept 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07158996
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 4 Sept 2025 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Have presence of 1 or more significant concurrent medical conditions per investigator judgment
Other illness
- Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth
- Active or history of gastric antral vascular ectasia
- 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 a diagnosis or history of malignant disease within 5 years prior to Screening
Lab values
- Inadequate clinical laboratory parameters at Screening
Other
- Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study
- Inability to comply with contraception requirements as specified in the protocol
Criteria the registry did not label
- ICriteria: Inclusion Criteria:
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.