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Tests treatment safety and results for Systemic Lupus Erythematosus (SLE)
Official title Safety Study of CC312 in Autoimmune Disease Patients
ClinicalTrials.gov ID: NCT06888960
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 systemic lupus erythematosus (sle).
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-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy.
- 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 and older
You may be able to join if
- people who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as people, and sign...
- Age ≥18 years (inclusive, based on the time of signing ICF), male or female.
- For SLE:
- people who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/1997 American College of Rheumatology (ACR)...
- SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;
You likely can't join if
- people who have severe lupus nephritis (defined as urinary protein \>6 g/24 h or serum creatinine \>2.5 mg/dL or 221 μmol/L), or required treatment...
- people who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to...
- Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or...
- Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and...
- Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell/bone marrow transplantation.
- Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.
See the full eligibility criteria
Who can join
- people who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as people, and sign the informed consent form (ICF).
- Age ≥18 years (inclusive, based on the time of signing ICF), male or female.
- For SLE:
- people who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/1997 American College of Rheumatology (ACR) diagnostic classification criteria;
- SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;
- Meet one of the following conditions: antinuclear antibody (ANA) determined to be positive during the screening period, or anti-dsDNA antibodies higher than normal levels at screening, or anti-Sm antibodies higher than...
- Before the first dose of the investigational drug, people must have received at least one of the following standard treatments for 12 weeks, and the dose must have been stable for at least 30 days (dose reduction is...
- For IIM:
- According to the 2017 EULAR/ACR Classification Criteria, diagnosed as possible or definite IIM-possible IIM: with a score of 5.5 points without biopsy; definite IIM: with a score of 6.7 points with biopsy;
- Meeting one of the following criteria: During or before the screening period, confirmed to have at least one positive myositis-specific autoantibody (MSA), myositis-associated autoantibody (MAA), or ANA;
- Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: the use of glucocorticoids (prednisone \>1 mg/kg/d or equivalent dose) and/or at least one...
- For IIM:
- people who are diagnosed with SSc according to the 2013 EULAR/ACR diagnostic classification criteria;
- Meets one of the following criteria: positive ANA confirmed during or before the screening period, or at least one positive SSc-related antibody profile (such as Scl70, Th/To, RP11/12, U3RNP autoantibodies);
- Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: using glucocorticoids (prednisone \> 0.5 mg/kg/d or equivalent dose) and cyclophosphamide, and any of...
- For RA:
- Diagnosed with RA according to the 2010 EULAR/ACR diagnostic classification criteria;
- Disease Activity Score DAS28-ESR \>3.2 (i.e., moderate activity or higher) during the screening period;
- Failure after treatment with at least one conventional disease-modifying antirheumatic drug (DMARD) and/or at least one targeted synthetic DMARD (tsDMARD)/biologic DMARD (bDMARD) (defined as no remission after at least...
- At screening, if the subject is taking prednisone or an equivalent dose of a glucocorticoid, the dose must be ≤10 mg/day and stable for at least 4 weeks before the first dose;
- The subject must have discontinued traditional Chinese medicine for the treatment of RA for ≥4 weeks before the first dose;
- Other DMARDs, except for methotrexate (MTX) (people who have been on routine MTX treatment for 12 weeks before enrollment, with a stable MTX dose for 4 weeks before enrollment), must meet the washout period...
- For ITP:
- Diagnosed with ITP according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition);
- Ineffective response or relapse after at least one prior treatment regimen (including but not limited to TPO mimetics/agonists, corticosteroids, immunoglobulins, azathioprine, cyclophosphamide, and/or rituximab);
- At least 2 platelet count measurements (with an interval of more than 24 hours) from the screening period to before the first dose, with an average platelet count \ 35×109/L;
- If receiving standard background therapy for ITP, the dose and frequency of this therapy should be stable for at least 4 weeks (dose change ≤10%) before the first dose.
- For AIHA:
- Diagnosed with AIHA according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Autoimmune Haemolytic Anaemia (2022 Edition);
- Poor response after at least first-line treatment (corticosteroids);
- Presence of anaemia-related symptoms during the screening period;
- The dose of supportive care must be stable for at least 4 weeks before the first dose.
- Laboratory test results: Complete blood count:
- SLE, SSc, and IIM: Absolute neutrophil count ≥1.0 x109/L, haemoglobin ≥60 g/L, platelets ≥50 x109/L;
- RA: Neutrophil count ≥1.5 x109/L, haemoglobin ≥90 g/L, platelets ≥100 x109/L;
- ITP: Absolute neutrophil count ≥1.0 x109/L, haemoglobin ≥70 g/L, platelets ≥10 x109/L;
- AIHA: Absolute neutrophil count ≥1.0 x109/L, platelets ≥50 x109/L (≥10 x109/L for patients with Evans syndrome and transfusion is permitted). Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase...
- Left ventricular ejection fraction (LVEF) ≥50%.
- Female people of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. Additionally, they must agree to refrain from collecting or donating eggs...
- Male people with reproductive potential must agree to use effective contraception from the screening period to 6 months after the last dose, and have no plans for reproduction or sperm donation. During this period...
What rules you out
- people who have severe lupus nephritis (defined as urinary protein \>6 g/24 h or serum creatinine \>2.5 mg/dL or 221 μmol/L), or required treatment of active nephritis with protocol-prohibited drugs, or required...
- people who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, posterior reversible encephalopathy syndrome...
- Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or cardiac involvement due to non-IIM causes (e.g., stroke).
- Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active...
- Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell/bone marrow transplantation.
- Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.
- IgA deficiency (serum IgA level \<10 mg/dL).
- Have participated in any other clinical trials (including cell or gene therapy) within 4 weeks before screening or within 5 half-lives of the investigational product (whichever is longer).
- Have received CAR-T therapy within 6 months before screening.
- Have received B-cell depleting drug rituximab or equivalent treatments (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be demonstrated that B cells have returned to pre-treatment levels...
- Have received anti-SLE treatments (e.g., Saphnelo) other than standard therapy within 3 months before screening or within 5 half-lives of the investigational product (whichever is longer).
- Have received a live/attenuated vaccine within 4 weeks before screening or plans to receive a live/attenuated vaccine during the study.
- Active infection.
- History of Grade 3-4 (CTCAE v5.0) allergic reaction to another monoclonal antibody treatment, or known allergy to any component or excipient of the CC312 drug product (including recombinant proteins, polysorbate 80...
- Acknowledgement of or evidence of illicit drug use, drug abuse, or alcoholism.
- people who have received major surgery within 4 weeks before screening or minor surgery within 2 weeks; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria).
- History of any of the following cardiovascular diseases within 6 months before screening: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any...
- Any other serious underlying diseases (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation dysfunction, heart diseases), mental...
- Evidence of concurrent malignant tumors within less than 5 years before screening, excluding adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized...
- Pregnant or breastfeeding women.
- people with positive results for viral serological tests during the screening period: positive for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or...
- people with active or latent tuberculosis (positive T-SPOT) identified during the screening period.
- History of splenectomy treatment within 6 months prior to screening.
- ITP people: 1) Secondary immune thrombocytopenia secondary to SLE, chronic lymphocytic leukemia (CLL), immunodeficiency common variable (CVID), or antiphospholipid syndrome (APS); 2) Drug-induced thrombocytopenia; 3)...
- ITP and AIHA people: Abnormal prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) that are considered clinically significant by the investigator.
- Other people whom the investigator judges to be unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China, 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.