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Tests treatment safety and results for SLE - Systemic Lupus Erythematosus
Official title Safety and Efficacy Study of CC312 for Moderate to Severe SLE
ClinicalTrials.gov ID: NCT07177911
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 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
- SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.
- Meet at least one of the following criteria: positive antinuclear antibody (ANA) ≥1:80 at screening, positive anti-dsDNA antibody at screening, or...
You likely can't join if
- Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \>6 g/24 h, or serum creatinine \>2.5 mg/dL or 221 μmol/L, or...
- Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident...
- 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, except for Sjögren's syndrome.
- IgA deficiency (serum IgA level \<10 mg/dL).
- Abnormal laboratory findings at screening: Liver function: AST/ALT or total bilirubin \>2× upper limit of normal (ULN); Hematology: hemoglobin \<85...
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 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
- SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.
- Meet at least one of the following criteria: positive antinuclear antibody (ANA) ≥1:80 at screening, positive anti-dsDNA antibody at screening, or positive anti-Sm antibody at screening.
- Have had an inadequate response to at least two standard therapies (e.g., corticosteroids, antimalarials, immunosuppressants, biologics) prior to screening, including at least one immunosuppressant and/or biologic...
- Females of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose and refrain from oocyte collection or donation during this period. Their male partners...
- Males of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation. Their female partners of childbearing...
What rules you out
- Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \>6 g/24 h, or serum creatinine \>2.5 mg/dL or 221 μmol/L, or requiring prohibited medications for active nephritis per protocol, or...
- Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, CNS vasculitis) within 8 weeks prior to screening...
- 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, except for Sjögren's syndrome.
- IgA deficiency (serum IgA level \<10 mg/dL).
- Abnormal laboratory findings at screening: Liver function: AST/ALT or total bilirubin \>2× upper limit of normal (ULN); Hematology: hemoglobin \<85 g/L, WBC \<2.5×10⁹/L, neutrophil count \<1.0×10⁹/L, platelet 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 6 months prior to screening, unless B-cell levels have 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 infection within 14 days prior to screening (bacterial, viral, fungal, parasitic, or other).
- History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (including recombinant proteins, polysorbate 80, etc.). Patients with transient...
- 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: NYHA Class III/IV heart failure, myocardial infarction, unstable angina, uncontrolled/symptomatic atrial arrhythmia, ventricular arrhythmia, or other...
- 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.
- Grade ≥2 bleeding within 30 days prior to screening, or requiring long-term anticoagulants (e.g., warfarin, LMWH, factor Xa inhibitors).
- Pregnant or lactating women.
- Positive screening for: tuberculosis (PPD skin test or TB-IGRA, unless with prior adequate anti-TB treatment and no current signs), HIV antibody, HBsAg or HBcAb, HCV antibody, or TP antibody.
- Any other condition deemed ineligible by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, 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 Chengdu, 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.