Clinical Study of Cizutamig in Systemic Lupus Erythematosus

NCT07215663 | Recruiting Phase 1

• 1 other identifier: CND106-103
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (11)

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

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: body temperature

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: heart rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: respiratory rate

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: blood pressure

  Baseline to Month 12

• Changes from baseline in vital signs through end of study: pulse oximetry

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: PR interval

  Baseline to Month12

• Changes from baseline in ECG parameters through end of study: QRS interval

  Baseline to Month 12

• Changes from baseline in ECG parameters through end of study: QTcF interval

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: serum chemistry

  Baseline to Month 12

• Changes from baseline in safety laboratory assessments through end of study: hematology

  Baseline to Month 12

Secondary Outcomes (6)

• Pharmacokinetic (PK) for Cizutamig: Cmax

  Baseline to Month 12

• PK parameters for Cizutamig: time of maximum concentration

  Baseline to Month 12

• PK parameters for Cizutamig: area under the concentration-time curve

  Baseline to Month 12

• PK parameters for Cizutamig: clearance

  Baseline to Month 12

• PK parameters for Cizutamig: volume of distribution

  Baseline to Month 12

Study Arms (1)

Cizutamig

EXPERIMENTAL

Drug: Cizutamig

Interventions

Cizutamig DRUG

Cizutamig will be dosed according to the protocol

Also known as: CND106

Cizutamig

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Liu Tian

CONTACT

+86 17621830227; liu@candidrx.com

Study Design

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 10, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)