A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-69
SponsorBeijing Boren Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Relapsed/Refractory Sjögren's Syndrome (SS) 2.1Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary Sjögren's Syndrome.
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
AFN50 injection
Biological/VaccineIntravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) that encapsulate RNA encoding a Chimeric Antigen Receptor.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: AFN50 treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Event
The incidence and severity of adverse events determined to be related to AFN50 treatment, as assessed per CTCAE v5.0.
Time frame
3 monthsSecondary outcomes
1
In vivo CAR T cell generation
The counts, proportions and sustained days of CAR-T cells in the peripheral blood
Time frame
Day -28 to 28 days2
B cell ratios and counts in peripheral blood
Assessment of the change of B cell ratios and counts in peripheral blood after AFN50 treatment
Time frame
Day -28 to 12 months3
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.
Time frame
Day -28 through Month 124
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.
Time frame
Day-28 to12 monthsSponsors and contacts
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Source ClinicalTrials.gov