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New treatment option for SLE - Systemic Lupus Erythematosus
Official title A Study of CC312 for Relapsed/Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07193810
What this study is testing
What is CC312?
CC312 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sle - systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the...
- Aged 18-65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
- For Systemic Lupus Erythematosus (SLE):
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria；
- Meet at least one of the following: positive antinuclear antibody (ANA) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening；
You likely can't join if
- Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \>6 g/24 h, serum creatinine \>2.5 mg/dL or 221 μmol/L)...
- Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident...
- Other types of idiopathic inflammatory myopathies: inclusion body myositis, amyotrophic diabetes, or juvenile myositis; patients with severe muscle...
- SSc-related pulmonary hypertension requiring treatment; rapidly progressive SSc-related lower gastrointestinal (small/large intestine) involvement...
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Other concurrent autoimmune diseases requiring systemic therapy.
See the full eligibility criteria
Who can join
- Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Aged 18-65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
- For Systemic Lupus Erythematosus (SLE):
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria；
- Meet at least one of the following: positive antinuclear antibody (ANA) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening；
- Had an inadequate response or relapse after standard therapy, defined as any of the following (alone or combined): glucocorticoids, antimalarials (hydroxychloroquine), immunosuppressants (including mycophenolate...
- At screening, meet SLEDAI-2000 ≥7 and have at least one BILAG A or two BILAG B organ domain scores；
- Prior to the first dose, people must have received glucocorticoids and/or antimalarials and/or immunosuppressants for ≥12 weeks, with stable doses for ≥30 days；
- If receiving oral glucocorticoids (e.g., prednisone), the dose must be ≤40 mg/day at screening and during the screening period；
- If using glucocorticoids alone, the dose must be ≥7.5 mg/day prednisone (or equivalent).
- For Idiopathic Inflammatory Myopathy (IIM):
- Diagnosed with possible or definite IIM per the 2017 EULAR/ACR classification criteria (≥5.5 points without biopsy; ≥6.7 points with biopsy) ；
- Have at least one positive myositis-specific autoantibody (MSA) , myositis-associated autoantibody (MAA), or ANA at or prior to screening；
- Had an inadequate response or relapse after conventional therapy, defined as glucocorticoids (prednisone \>1 mg/kg/day or equivalent) and ≥1 immunomodulatory drug (immunosuppressants: azathioprine, mycophenolate...
- Have active IIM at screening, defined as meeting ≥3 of MMT-8 total score ≤141/150 with ≥20% strength loss in affected muscles; Physician global activity ≥2; Patient global activity ≥2; myositis disease activity...
- Prior to the first dose, people must have received glucocorticoids and/or immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. Glucocorticoid dose...
- If a subject is receiving oral glucocorticoids alone, the dose should be at least 7.5 mg/day of prednisone (or an equivalent dose of other glucocorticoids).
- For Systemic Sclerosis (SSc):
- Diagnosed with diffuse cutaneous SSc per the 2013 EULAR/ACR criteria ；
- Have positive ANA and/or SSc-related antibodies；
- Disease duration ≤5 years (from initial diagnosis)；
- Had an inadequate response or relapse after conventional therapy. Conventional therapy is defined as treatment with glucocorticoids plus any of the following immunomodulatory agents: cyclophosphamide, mycophenolate...
- Modified Rodnan Skin Score (mRSS) ≥15 and ≤30 at screening with progression within 6 months；
- Prior to the first dose, people must have received glucocorticoids and/or immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. The glucocorticoid dose...
- Females of childbearing potential must use highly effective contraception from screening until 6 months after the last dose, refrain from oocyte donation, and ensure male partners use effective contraception.
- Males of childbearing potential must use effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation, and ensure female partners use effective contraception.
What rules you out
- Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \>6 g/24 h, serum creatinine \>2.5 mg/dL or 221 μmol/L), requirement of prohibited medications for active nephritis per protocol, need...
- Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis) within 8 weeks prior to screening.
- Other types of idiopathic inflammatory myopathies: inclusion body myositis, amyotrophic diabetes, or juvenile myositis; patients with severe muscle damage or permanent weakness/cardiac involvement due to non-IIM causes...
- SSc-related pulmonary hypertension requiring treatment; rapidly progressive SSc-related lower gastrointestinal (small/large intestine) involvement requiring parenteral nutrition; active gastric antral vascular ectasia...
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Other concurrent autoimmune diseases requiring systemic therapy.
- IgA deficiency (serum IgA level \<10 mg/dL).
- Abnormal laboratory findings at screening: Liver function: AST/ALT \>2× upper limit of normal (ULN) (except for IIM patients with elevated muscle enzymes); Hematology: hemoglobin \<85 g/L, white blood cell count...
- Participation in any other clinical trial (including cell or gene therapy) within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).
- Received CAR-T therapy within 6 months prior to screening.
- Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19/CD20/BAFF) within 1 month prior to screening, unless B-cell levels returned to pre-treatment or normal ranges.
- Received non-standard anti-SLE therapies (e.g., Saphnelo) within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening.
- Received live/attenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.
- Active severe infection requiring antibiotic treatment within 14 days prior to screening.
- History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (e.g., recombinant proteins, polysorbate 80). Patients with transient (≤24 h)...
- Evidence of drug abuse, substance abuse, or alcohol addiction.
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to screening; wounds must be fully healed (procedures like catheter placement are excluded).
- History of cardiovascular events within 6 months prior to screening: New York Heart Association (NYHA) Class III/IV heart failure, myocardial infarction, unstable angina, uncontrolled/symptomatic atrial arrhythmia...
- Any other severe underlying disease (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, GI bleeding, severe coagulation disorders), psychiatric disorder, or social circumstances that may...
- Concurrent malignancy diagnosed within \<5 years prior to screening.
- Pregnant or lactating women.
- Positive serology for Human Immunodeficiency Virus (HIV) antibody, Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, or Treponema pallidum (TP) antibody at screening.
- Active or latent tuberculosis at screening (positive TB-IGRA test).
- Any other condition deemed ineligible by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Deyang, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Deyang, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.