Actively Recruiting
Safety and Efficacy Study of CC312 for Moderate to Severe SLE
Led by CytoCares Inc · Updated on 2025-09-17
32
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).
CONDITIONS
Official Title
Safety and Efficacy Study of CC312 for Moderate to Severe SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial and agree to participate with informed consent
- Aged 18 to 65 years
- Diagnosed with systemic lupus erythematosus (SLE) per 2019 EULAR/ACR criteria
- SLEDAI-2000 score ≥7 with specific BILAG domain activity despite standard therapy
- Positive for ANA (≥1:80), anti-dsDNA, or anti-Sm antibodies at screening
- Inadequate response to at least two standard therapies including immunosuppressants or biologics
- Stable doses of corticosteroids, antimalarials, or immunosuppressants for at least 12 weeks before screening
- Females of childbearing potential and their male partners agree to effective contraception from screening until 6 months after last dose
- Males of childbearing potential agree to effective contraception from screening until 6 months after last dose
You will not qualify if you...
- Severe lupus nephritis within 8 weeks before screening
- Central nervous system disorders within 8 weeks before screening
- History of major organ or stem cell transplantation
- Other autoimmune diseases needing systemic therapy except Sjögren's syndrome
- IgA deficiency (serum IgA <10 mg/dL)
- Abnormal liver, hematology, or renal lab values at screening
- Participation in another clinical trial within 4 weeks or 5 half-lives of the investigational product
- CAR-T therapy within 6 months before screening
- Treatment with B-cell-depleting agents within 6 months unless B-cell levels normalized
- Recent use of non-standard anti-SLE therapies within 3 months or 5 half-lives
- Live or attenuated vaccination within 4 weeks before screening or planned during trial
- Active infection within 14 days before screening
- History of severe allergic reaction to monoclonal antibodies or CC312 components
- Drug, substance, or alcohol abuse
- Recent major or minor surgery unless wounds fully healed
- Cardiovascular events within 6 months before screening
- Severe underlying diseases, psychiatric disorders, or social issues affecting trial participation
- Malignancy diagnosed within 5 years before screening
- Significant bleeding or need for long-term anticoagulants
- Pregnant or lactating women
- Positive screening for tuberculosis, HIV, hepatitis B or C, or syphilis
- Any other condition judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
C
CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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