A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus

NCT07538154 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SCTC21C-C201
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

SLE

Outcome Measures

Primary Outcomes (2)

• Phase 1: safety and tolerability of SCTC21C

  To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)

  From first dose to Week 48

• Phase II: efficacy of SCTC21C

  Percentage of participants who achiened an mSRI-4 response at W24

  Up to Week 24

Secondary Outcomes (6)

• dose escalation part#SRI4/5/6/7/8

  up to Week 48

• Dose- escalation # mSRI4/5/6/7/8

  up to Week 48

• Dose-escalation part # BILAG

  up to Week 48

• Dose-escalation part # SLE flare

  Up to Week 48

• Dose-escalation part # immunogenicity

  up to Week 48

Study Arms (1)

experimental: SCTC21C

EXPERIMENTAL

SCTC21C will be administered to participants for about 24 weeks

Biological: SCTC21C

Interventions

SCTC21C BIOLOGICAL

SCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts

experimental: SCTC21C

Eligibility Criteria

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

You may qualify if:

• Aged 18-75 years;
• Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
• SELENA-SLEDAI ≥8 at screening;
• Positive immunological markers within 12 months prior to baseline;
• Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;
• All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug
• Understanding of the study procedures and voluntary signing of the informed consent form

You may not qualify if:

• Severe active or unstable lupus-related neuropsychiatric disorders;
• Combined with active infections, malignant tumors, or other autoimmune diseases;
• Catastrophic antiphospholipid syndrome;
• severe lupus nephritis;
• Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;
• Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
• Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;
• Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;
• In accordance with the protocol requirements, participants with abnormal laboratory test results;
• Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;
• participants with a history of tuberculosis or latent tuberculosis infection;
• Diagnosed with type 1 or type 2 diabetes with poor control;
• Uncontrolled hypertension;
• Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;
• Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

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: April 12, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04