Actively Recruiting
A Study of CC312 for Relapsed/Refractory Autoimmune Diseases
Led by CytoCares Inc · Updated on 2026-04-14
6
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.
CONDITIONS
Official Title
A Study of CC312 for Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the trial and voluntarily sign informed consent
- Age between 18 and 65 years inclusive
- Diagnosed with Systemic Lupus Erythematosus (SLE) meeting 2019 EULAR/ACR criteria and positive for ANA, anti-dsDNA, or anti-Sm antibodies
- Had inadequate response or relapse after at least 3 months of standard SLE therapies including glucocorticoids, antimalarials, immunosuppressants, or biologics
- At screening, SLEDAI-2000 score of 7 or higher with specific BILAG organ domain scores
- Stable doses of glucocorticoids and/or antimalarials and/or immunosuppressants for at least 12 weeks prior to dosing
- For glucocorticoids alone, prednisone dose between 7.5 and 40 mg/day at screening
- Diagnosed with possible or definite Idiopathic Inflammatory Myopathies (IIM) per 2017 EULAR/ACR criteria
- Positive myositis-specific or associated autoantibodies or ANA
- Inadequate response or relapse after at least 3 months of glucocorticoids and one immunomodulatory drug
- Active IIM at screening meeting muscle strength, disease activity, and enzyme criteria
- Stable glucocorticoid and immunosuppressant doses for specified durations prior to dosing
- Glucocorticoid dose up to 60 mg/day prednisone at screening
- Diagnosed with diffuse cutaneous Systemic Sclerosis (SSc) per 2013 EULAR/ACR criteria
- Positive ANA or SSc-related antibodies
- Disease duration 5 years or less from diagnosis
- Inadequate response or relapse after at least 6 months of conventional therapy
- Modified Rodnan Skin Score between 15 and 30 with recent progression
- Stable glucocorticoid dose not exceeding 10 mg/day prednisone and immunosuppressants for specified durations
- Females of childbearing potential must use effective contraception from screening until 6 months after last dose
- Males of childbearing potential must use effective contraception from screening until 6 months after last dose
You will not qualify if you...
- Severe lupus nephritis within 8 weeks prior to screening or need for prohibited nephritis medications
- Central nervous system disorders within 8 weeks prior to screening
- Other idiopathic inflammatory myopathies such as inclusion body myositis or juvenile myositis or severe muscle damage from non-IIM causes
- SSc-related pulmonary hypertension needing treatment or rapidly progressive gastrointestinal involvement
- History of major organ or stem cell transplantation
- Other autoimmune diseases requiring systemic treatment
- IgA deficiency with serum IgA less than 10 mg/dL
- Abnormal liver or blood lab values exceeding specific thresholds
- Participation in other clinical trials recently or within drug half-lives
- Recent CAR-T therapy or B-cell depleting treatments before screening
- Recent non-standard anti-SLE therapies or live vaccination
- Active severe infection requiring antibiotics recently
- History of severe allergic reactions to monoclonal antibodies or components of CC312
- History of drug, substance, or alcohol abuse
- Recent major or minor surgery with unhealed wounds
- Recent significant cardiovascular events or heart failure
- Other serious diseases or psychiatric or social conditions interfering with study
- Recent or current cancer diagnosis
- Pregnant or breastfeeding women
- Positive HIV, Hepatitis B or C, or syphilis serology
- Active or latent tuberculosis
- Any other investigator-determined ineligibility condition
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Deyang People's Hospital
Deyang, Sichuan, China, 618000
Actively Recruiting
Research Team
C
CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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