SNC116 Therapy for Refractory Systemic Lupus Erythematosus
China28 participantsStarted 2026-08
Plain-language summary
This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years, ≤ 65 years, gender not restricted.
. For refractory systemic lupus erythematosus (SLE), the following criteria must be met:
. 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.
. Refractory lupus nephritis (LN) requires simultaneous satisfaction of: According to the classification of the International Society of Nephrology (ISN)/Renal Pathology Society (RPS), biopsy-proven type III, IV, or V, or type III/IV combined with type V, activity index (AI) ≥ 1, diagnosed as active LN; Renal biopsy must be conducted within one year before screening or during the screening period; Urine protein to creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without red blood cell casts in active urinary sediment;
. Within 7 days before SNC116 administration, the blood routine test results must meet the following requirements (excluding SLE activity caused by surgery and assessed by the investigator):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early Phase 1 trial for SNC116 that hasn't started recruiting yet, what does that mean for how much safety information is currently available about this therapy in people with lupus?
2Given that the primary goal here is to evaluate safety rather than to prove the treatment works, what would my doctor consider an acceptable risk level for me to participate in a first-in-human type study given my current disease severity?
3My lupus has been described as refractory, meaning it hasn't responded well to other treatments — before considering an experimental option like this, are there any standard or approved therapies my doctor feels we haven't fully tried yet?
4Since the trial isn't recruiting yet, how would my doctor recommend I stay informed about when it opens, and what would they want to reassess about my health status before deciding whether it's worth pursuing at that point?
5What does 'refractory' mean in the context of this trial's eligibility, and does my doctor think my treatment history would actually fit what the researchers are likely looking for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Evaluation
Timeframe: Within 3 months after SNC116 treatment.
2
Safety Evaluation
Timeframe: Within 28 days after SNC116 treatment.
Trial details
NCT IDNCT07748156
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. 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).
. Subjects who have previously received any treatment using vesicular virus G glycoprotein pseudotyped viruses.
. Subjects who have previously received CD19 CAR-T cell therapy or other genetically modified T cell therapy.
. Subjects with organ dysfunction, meeting any of the following criteria:
. Serum ALT and AST \> 2.5 times the upper limit of normal;