This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus.
Age ≥ 18 years, ≤ 65 years, gender not restricted.
Conform to the classification criteria of SLE of the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) in 2019
Disease activity score SLEDAI-2000 ≥ 6, and at least one BILAG-2004 index of the British Isles Lupus Activity Group (severe manifestations) or two B-class (moderate manifestations) organ scores, or both; or disease activity score SLEDAI-2000 ≥ 8
Definition of recurrence/refractory: After receiving conventional treatment for at least 6 months, the disease remains active. Conventional treatment is defined as using glucocorticoids and/or antimalarial drugs, and any one or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents/molecular targeted drugs, including CD20 monoclonal antibodies, belimumab, tepredipine, tofacitinib, baricitinib, upadacitinib, etc.
Individuals who have had any allergic reaction, hypersensitivity reaction, intolerance or contraindication to the components of SNC116 or the drugs that may be used in the study (such as tocilizumab), or who have previously experienced severe allergic reactions.
Subjects who had uncontrolled active infections requiring intravenous antibiotics, antiviral or antifungal drugs, etc. within 7 days before the administration of SNC116.
Subjects with a primary immunodeficiency disorder.
Subjects who had malignant tumors requiring treatment or evidence of recurrence within 2 years before screening (excluding: non-melanoma skin cancer that has been fully cured, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma, thyroid cancer, and other localized carcinomas).
Single group
SNC116
DrugSubjects will receive SNC116 injection per different dose level
Safety Evaluation: Incidence, characteristic and severity of all adverse events
Safety Evaluation: DLT (Dose limit toxicity)
SRI-4 (Systemic Lupus Erythematosus Responder Index 4) Response
LLDAS (Lupus Low Disease Activity State)
DORIS (Definitions Of Remission In SLE)
SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000)
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Shanghai Simnova Biotechnology Co.,Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
