A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases

Recruiting now · Early Phase 1

Conditions studied: Relapsed/Refractory Autoimmune Diseases

In brief

This study is a single-arm, open-label, single-centre exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of AFN50 Injection in adult patients with B-cell-mediated refractory/replapased autoimmune diseases.

Key facts

Study ID

NCT07448298

Run by

Beijing Boren Hospital

People needed

18

Starts

2026-03-09

Expected to finish

2029-02-28

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Inclusion Criteria 1.1 Must be capable of understanding and voluntarily providing written informed consent.
• 2 Age 18 to 69 years (inclusive), any gender. 1.3 Adequate bone marrow, coagulation, cardiac, pulmonary, hepatic, and renal function at screening:
• Bone Marrow Function:
• Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L (no use of granulocyte colony-stimulating factor (G-CSF) within 7 days before screening; for long-acting G-CSF, a 14-day interval is required); ② Haemoglobin (Hb) ≥90 g/L (no red blood cell transfusion within 14 days before screening; use of recombinant human erythropoietin is permitted); ③ Platelet count (PLT) ≥75 × 10⁹/L; absolute lymphocyte count (ALC) ≥0.5 × 10⁹/L.
• Coagulation Function: International normalised ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).
• Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50% as shown by echocardiography (ECHO).
• Pulmonary Function: Dyspnea ≤ CTCAE Grade 1, and pulse oxygen saturation (SpO₂) >92% on room air.
• Hepatic Function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 × ULN; total bilirubin ≤1.5 × ULN.
• Renal Function: Creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, without requiring fluid support.
• 4 Baseline oxygen saturation >92% without supplemental oxygen. 1.5 Non-pregnant/non-lactating subjects. Women of childbearing potential must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilisation or are postmenopausal for at least 2 years are not considered to be of childbearing potential) and must be willing to use contraception for 12 months following drug infusion.
• Disease-Specific Inclusion Criteria：
• Relapsed/Refractory Systemic Lupus Erythematosus (SLE) 1.1 Meet the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
• 2 SLEDAI-2K score ≥6; if the score includes low complement and/or anti-dsDNA antibodies, the SLEDAI-2K clinical symptom score after excluding these two items must be ≥4.
• 3 History of SLE for at least 6 months, with disease remaining active or relapsing despite receiving stable standard therapy for at least 8 weeks (drug doses stable for the past 2 weeks).
• 4 Oral glucocorticoids (prednisone or equivalent) at a daily dose ≥7.5 mg and ≤30 mg; if combined with immunosuppressants, there is no minimum daily dose requirement.
• 5 At least two immunosuppressants (including hydroxychloroquine) have been used in a standardised manner.
• 6 Screening tests meet: positive serum antinuclear antibody (ANA), and/or positive anti-double-stranded DNA (anti-dsDNA) antibody, and/or hypocomplementemia (low C3 and/or low C4).
• 7 Definition of relapsed/refractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Stable use, alone or in combination, of the following drugs: non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, glucocorticoids, immunosuppressants (including but not limited to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine), targeted drugs (including but not limited to belimumab, telitacicept, eculizumab, rituximab).
• Relapsed/Refractory Sjögren's Syndrome (SS) 2.1Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary Sjögren's Syndrome.
• 2 Definition of relapsed/refractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg/kg/day) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for >6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.
• Refractory Myasthenia Gravis (MG) 3.1 Meet the diagnostic criteria for generalized myasthenia gravis as per the Chinese guidelines for the diagnosis and treatment of MG (2025 edition).
• 2 Myasthenia Gravis Foundation of America (MGFA) clinical classification: Type II, III, or IV.
• 3 Positive serology for acetylcholine receptor antibody (AChR-Ab), or muscle-specific tyrosine kinase antibody (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibody (LRP4-Ab) at screening, or documented history of positive AChR-Ab, MuSK-Ab, or LRP4-Ab.
• 4 Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥6, with ocular-related scores comprising less than 50% of the total score.
• 5 Myasthenia Gravis (QMG) score ≥8, with at least 4 individual item scores being ≥2 points.

You may not qualify if…

• General Exclusion Criteria 1.1 Individuals with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA or titer above the detection threshold; positive hepatitis C virus (HCV) antibody with detectable HCV RNA or titer above the detection threshold; positive human immunodeficiency virus (HIV) antibody; detectable cytomegalovirus (CMV) DNA or level above the detection limit; positive syphilis antigen or antibody.
• 2 Presence of other uncontrolled active infections. 1.3 History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation.
• 4 Received any mRNA-LNP product or other LNP-based therapy within the past 2 years and has a history of allergy to LNPs or their components.
• 5 Received live vaccination within the past 30 days. 1.6 History of any severe cardiovascular disease within 6 months prior to screening, including: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease.
• 7 Pregnant or lactating women. 1.8 Individuals with asthma or a history of severe allergies. 1.9 According to the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up or compliance with study participation requirements.
• 10 Other unspecified reasons that, in the opinion of the investigator, render the patient unsuitable for enrollment.
• Disease-Specific Exclusion Criteria
• Relapsed/Refractory Systemic Lupus Erythematosus: Concurrent neuropsychiatric lupus; thrombotic thrombocytopenic purpura (TTP)/microangiopathy (TMA).
• Relapsed/Refractory Sjögren's Syndrome: Concurrent liver cirrhosis; concurrent aplastic anaemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disorders (MPD); drug-induced thrombocytopenia; TTP/TMA.
• Relapsed/Refractory Myasthenia Gravis: Presence of an uncontrolled myasthenic crisis within 2 weeks prior to screening.
• Relapsed/Refractory or Progressive Diffuse Cutaneous Systemic Sclerosis: NYHA Class IV cardiac function; presence of moderate to severe pulmonary hypertension (mean pulmonary artery pressure >40 mmHg by echocardiography); FVC <45% of predicted value; DLCO <40% of predicted value; significant abnormalities on HRCT not attributable to SSc; persistent unexplained hematuria (>5 red blood cells per high-power field) or creatinine clearance <40 mL/min; prior history of autologous stem cell transplantation; signs of renal crisis; active gastric antral vascular ectasia.
• Relapsed/Refractory or Progressive Idiopathic Inflammatory Myopathy: Drug-induced myositis; inclusion body myositis; cancer-associated myositis (myositis occurring within 2 years of cancer diagnosis).
• Relapsed/Refractory ANCA-Associated Vasculitis:
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m²; if the participant has alveolar haemorrhage requiring invasive mechanical ventilation expected to last beyond the screening period; requiring dialysis or plasma exchange during the screening period; or prior kidney transplantation.

Where it is running

• Beijing GoBroad Boren Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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