A Study of Cizutamig in Systemic Sclerosis

NCT07158996 | Not Yet Recruiting Early Phase 1

• 1 other identifier: CND106-RUJN -1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study

  52weeks

Study Arms (1)

A study of cizutamig in patients with Systemic Sclerosis (Ssc)

EXPERIMENTAL

Drug: Biological: cizutamig

Interventions

Biological: cizutamig DRUG

Cizutamig will be dosed according to the protocol.

A study of cizutamig in patients with Systemic Sclerosis (Ssc)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Chengde Yang

CONTACT

13501717833; yangchengde@sina.com

Qiongyi Hu

CONTACT

18317071395; huqiongyi131@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 8, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share