AzTrials
AzTrials

Relapsed/Refractory Autoimmune DiseasesEarly Phase 1NCT07448298

A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases

A Early Phase 1 study testing AFN50 injection in people with Relapsed/Refractory Autoimmune Diseases, run by Beijing Boren Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Relapsed/Refractory Autoimmune Diseases
What is being tested?
AFN50 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
9 Mar 2026to 30 Apr 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. General Inclusion Criteria 1.1 Must be capable of understanding and voluntarily providing written informed consent.
  • 1.2 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).
Show all 41Show fewer
  • 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.
  • 1.4 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.
  • 1.2 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.
  • 1.3 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).
  • 1.4 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.
  • 1.5 At least two immunosuppressants (including hydroxychloroquine) have been used in a standardised manner.
  • 1.6 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).
  • 1.7 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.
  • 2.2 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).
  • 3.2 Myasthenia Gravis Foundation of America (MGFA) clinical classification: Type II, III, or IV.
  • 3.3 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.
  • 3.4 Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥6, with ocular-related scores comprising less than 50% of the total score.
  • 3.5 Myasthenia Gravis (QMG) score ≥8, with at least 4 individual item scores being ≥2 points.
  • 3.6 Definition of refractory: Ineffective to conventional therapy or disease reactivation following remission.
  • Relapsed/Refractory or Progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) 4.1 Meet the 2013 ACR classification criteria for systemic sclerosis, with diffuse cutaneous involvement.
  • 4.2 Presence of interstitial lung disease: evidence of interstitial changes with ground-glass opacity on chest HRCT and forced vital capacity (FVC) or diffusing capacity of the lung for carbon monoxide (DLCO) <70% of predicted value on pulmonary function tests.
  • 4.3 Definition of relapsed/refractory: Ineffective to conventional therapy or disease reactivation following remission.
  • 4.4 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.
  • 4.5 Definition of progressive disease:
  • Skin progression: Increase in modified Rodnan skin score (mRSS) >10%.
  • Lung disease progression: Decrease in FVC by 10%, or decrease in FVC by 5% accompanied by a decrease in DLCO by 15% (OMERACT progression).
  • Relapsed/Refractory or Progressive Idiopathic Inflammatory Myopathy (IIM) 5.1 Meet the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myopathies (including DM, PM, ASS, and NM).
  • 5.2 For patients with muscle involvement: Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician Global Activity (PhGA), Patient Global Activity (PtGA) or extra-muscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels 1.5 times the upper limit of normal).
  • 5.3 Positive myositis antibodies. 5.4 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.
  • 5.5 Definition of progressive disease: Rapidly progressive interstitial pneumonia occurring within a short period.
  • Relapsed/Refractory Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) 6.1 Meet the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.
  • 6.2 Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA). 6.3 Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total 63 points), indicating active vasculitis.
  • 6.4 The BVAS assessment must include at least one major item, at least three minor items, or at least two renal items (hematuria and proteinuria).
  • 6.5 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.

Who cannot join

  • 1. 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.
  • 1.2 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.
  • 1.4 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.
  • 1.5 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.
  • 1.7 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.
  • 1.10 Other unspecified reasons that, in the opinion of the investigator, render the patient unsuitable for enrollment.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Beijing GoBroad Boren Hospital

    Beijing

Other trials in China

About this study

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.

Read the detailed description

The study employs a "3+3" dose-escalation design with a total of 9-18 subjects enrolled. The objective is to evaluate the safety, tolerability, and primary efficacy of AFN50 injection in relapsing and refractory autoimmune disease. The primary endpoint is the incidence and severity of treatment-related adverse events, with a total follow-up period of approximately 24 months.

Being tested
AFN50 injection
Keywords
Autoimmune Diseases
Medical subject headings
Autoimmune Diseases

What participants receive

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

  • AFN50 injectionBiological

    Intravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) that encapsulate RNA encoding a Chimeric Antigen Receptor.

Study groups in NCT07448298
Study groupRoleWhat they receive
AFN50 treatment groupExperimentalIntravenous infusion therapy with a dose escalation design
Receives: Biological: AFN50 injection

What is being measured

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

  1. Adverse Event

    The incidence and severity of adverse events determined to be related to AFN50 treatment, as assessed per CTCAE v5.0.

    Measured: 3 months

Secondary outcomes (5)
  1. In vivo CAR T cell generation

    The counts, proportions and sustained days of CAR-T cells in the peripheral blood

    Measured: Day -28 to 28 days

  2. B cell ratios and counts in peripheral blood

    Assessment of the change of B cell ratios and counts in peripheral blood after AFN50 treatment

    Measured: Day -28 to 12 months

  3. Changes in the 2000 Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) relative to baseline in participants

    Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline to the month 12 follow-up visit. A total score can fall between 0 and 105, which determines changes in the disease activity of patients.

    Measured: Day -28 through Month 12

  4. SLE Responder Index-4 (SRI-4)

    Achievement of SRI-4 response at one or more scheduled study visits between baseline and the Month 12 follow-up.

    Measured: Day-28 to12 months

  5. Changes in the Physician's Global Assessment (PGA) relative to baseline

    A total score can range from 0.0 to 3.0, with higher scores indicating more severe disease activity.

    Measured: Day-28 to12 months

Timeline

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

  1. First posted4 Mar 2026
  2. Study start9 Mar 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Why it stopped: No participants.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07448298
Sponsor's protocol ID
KY2026-003-002
Status last verified
Oct 2026
First submitted
26 Feb 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing AFN50 injection in people with Relapsed/Refractory Autoimmune Diseases, run by Beijing Boren Hospital 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 41 inclusion and 14 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: withdrawn, as of the sponsor's last update on 15 Oct 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Adverse Event (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in