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Systemic Lupus ErythematosusEarly Phase 1NCT07748156

SNC116 Therapy for Refractory Systemic Lupus Erythematosus

A Early Phase 1 study testing SNC116 in people with Systemic Lupus Erythematosus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
SNC116
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
Oct 2026to Jan 2030
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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):
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
  • Absolute lymphocyte count (ALC) ≥ 0.5×10^9/L (or lymphocyte subpopulation detection CD3+ T cells ≥ 300 cells/μL);
  • Hemoglobin (Hb) ≥ 80 g/L;
  • Platelet count (PLT) ≥ 50×10^9/L.
  • During the screening period, serum pregnancy test results of fertile female subjects must be negative (women who have undergone surgical sterilization or have been menopausal for at least 2 years are considered to have no fertility). Fertile female subjects and male subjects must use highly effective contraceptive methods throughout the clinical study and within 2 years after the last study treatment.
  • Subjects must agree not to donate blood, organs, tissues, sperm/spirit and/or egg cells for at least 2 years after SNC116 treatment.
  • Voluntarily participate in the clinical trial and sign the informed consent form.

Who cannot join

  • 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.
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  • Subjects with organ dysfunction, meeting any of the following criteria:
  • Serum ALT and AST > 2.5 times the upper limit of normal;
  • Total bilirubin > 1.5 times the upper limit of normal, for those with Gilbert syndrome, total bilirubin > 3.0 times the upper limit of normal;
  • Creatinine clearance rate (estimated by the Cockcroft-Gault formula) < 30 ml/min;
  • Blood oxygen saturation ≤ 91% under indoor ventilation conditions without oxygen inhalation;
  • Left ventricular ejection fraction < 45%.
  • Subjects with clinically significant major cardiovascular diseases, including any of the following:
  • Had myocardial infarction within 6 months before screening;
  • Had unstable angina pectoris within 3 months before screening, or had evidence of active ischemic heart disease indicated by electrocardiogram and other examinations;
  • Uncontrolled and clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes, severe atrioventricular block, etc.);
  • For male subjects, QTcF ≥ 450 milliseconds, for female subjects, QTcF ≥ 470 milliseconds and the investigator judges it to be clinically significant;
  • Congestive heart failure of NYHA classification ≥ 3;
  • Poorly controlled hypertension (systolic pressure > 160 mmHg and/or diastolic pressure > 100 mmHg) or with hypertensive crisis or hypertensive encephalopathy;
  • Had deep vein thrombosis or pulmonary embolism within 6 months before screening;
  • Other cardiovascular diseases assessed by the investigator as being significantly high risk and not suitable for enrollment.
  • Meet any of the following criteria:
  • Human immunodeficiency virus (HIV) antibody positive;
  • Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and HBV-DNA above the detection limit of the testing method;
  • Positive for hepatitis C virus (HCV) antibody and HCV RNA above the detection limit;
  • Active syphilis (excluding false positives caused by the disease);
  • Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA detection (virus active);
  • Subjects who had active tuberculosis or latent tuberculosis that was not properly treated within 6 months before screening.
  • Subjects who had a history of or symptoms of severe central nervous system diseases within 6 months before screening (excluding simple trigeminal nerve disease; except for those caused by SLE activity, as assessed by the investigator). These include but are not limited to mental disorders, cerebrovascular diseases, encephalitis, brain injury, epilepsy, convulsions, aphasia, dementia, suicidal tendencies, etc. 11. Before receiving SNC116, the following drugs/treatments were administered:
  • Within 1 week, preventive treatment with short-acting oral antiretroviral drugs was received.
  • Within 1 week, small molecule drugs (such as JAK inhibitors) or iltiazumab were received.
  • Within 2 weeks or 3 half-lives (as determined by the investigator) received immunosuppressants, such as azathioprine (AZA), mycophenolate mofetil (MMF), methotrexate (MTX), cyclosporine (CsA), tacrolimus (FK506), cyclophosphamide (CYC), leflunomide (LEF).
  • Within 4 weeks received biologics (such as belimumab, tixagevimab, anifrolumab), experimental drugs/treatments (except for clear placebo-controlled groups), or plasma exchange treatment; for belimumab and tixagevimab, baseline B cell levels need to be recorded.
  • Within 6 months received anti-CD20 monoclonal antibodies (such as rituximab, obinutuzumab), and the peripheral blood CD19+ B cell count at screening needs to be ≥ 50 cells/μL.
  • Experienced major surgery within 4 weeks.
  • Received live vaccines within 4 weeks.
  • 12. Had other active autoimmune diseases and the investigator determined that they were not suitable to participate in this study.
  • 13. Pregnant, or lactating, or planning to become pregnant. 14. Had other serious or diagnosed medical conditions within 3 months before screening (such as severe pulmonary disease or oxygen-dependent dependence, or progressive renal function deterioration requiring dialysis treatment, or active gastrointestinal bleeding/ulcer/perforation, or uncontrolled serous cavity effusion, etc.), and the investigator believed that these conditions might affect the safety or study compliance of the subjects, and were not suitable to participate in this study.
  • 15. Exclusion criteria for SLE:
  • Diagnosed as drug-induced lupus; b) At screening, had lupus crisis, or severe central nervous system involvement (neuro-psychiatric lupus) of the subjects.
  • 16. Other situations that the investigator believed might affect the safety or study compliance of the subjects and were not suitable to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: An Exploratory Clinical Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetic Characteristics of SNC116 in the Treatment of Refractory Systemic Lupus Erythematosus

This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus.

Being tested
SNC116
Keywords
in vivo CAR-T, CD19, SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNC116Drug

    Subjects will receive SNC116 injection per different dose level

Study groups in NCT07748156
Study groupRoleWhat they receive
SNC116ExperimentalSubjects diagnosed with Refractory Systemic Lupus Erythematosus
Receives: Drug: SNC116

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Evaluation: Incidence, characteristic and severity of all adverse events

    Measured: up to 3 months post-infusion

  2. Safety Evaluation: DLT (Dose limit toxicity)

    Measured: up to 28 days post-infusion

Secondary outcomes (5)

  1. SRI-4 (Systemic Lupus Erythematosus Responder Index 4) Response

    Measured: up to End of Treatment (EOT) visit

  2. LLDAS (Lupus Low Disease Activity State)

    Measured: up to End of Treatment (EOT) visit

  3. DORIS (Definitions Of Remission In SLE)

    Measured: up to End of Treatment (EOT) visit

  4. SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000)

    Measured: up to End of Treatment (EOT) visit

  5. BILAG 2004 (British Isles Lupus Assessment Group 2004)

    Measured: up to End of Treatment (EOT) visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748156
Sponsor's protocol ID
SNC116-104
Status last verified
Jul 2026
First submitted
26 Jul 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently, this information is not shared. Should any future sharing arrangements be established, relevant updates will be promptly communicated through this channel.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SNC116 in people with Systemic Lupus Erythematosus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Evaluation: Incidence, characteristic and severity of all adverse events (time frame: up to 3 months post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07748156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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