Actively Recruiting
A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases
Led by Beijing Boren Hospital · Updated on 2026-03-11
18
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Age between 18 and 69 years inclusive
- Adequate bone marrow function: ANC ≥1.0 × 10⁹/L without recent G-CSF use; hemoglobin ≥90 g/L without recent transfusion; platelet count ≥75 × 10⁹/L; absolute lymphocyte count ≥0.5 × 10⁹/L
- Adequate coagulation function: INR or APTT ≤1.5 times upper limit of normal
- Cardiac function: LVEF ≥50% by echocardiography
- Pulmonary function: Dyspnea grade ≤1 and oxygen saturation >92% on room air
- Hepatic function: ALT and AST ≤2.5 times ULN; total bilirubin ≤1.5 times ULN
- Renal function: Creatinine clearance ≥50 mL/min without fluid support
- Baseline oxygen saturation >92% without supplemental oxygen
- Non-pregnant and non-lactating; women of childbearing potential must have negative pregnancy test and agree to contraception for 12 months post-infusion
- Specific disease criteria for relapsed/refractory systemic lupus erythematosus, Sjögren's syndrome, myasthenia gravis, diffuse cutaneous systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis as detailed in protocol
You will not qualify if you...
- Positive hepatitis B or C with detectable virus, HIV antibody positive, active CMV DNA, or positive syphilis tests
- Uncontrolled active infections
- History of major organ or bone marrow transplantation
- Received mRNA-LNP or other lipid nanoparticle therapy within past 2 years or allergy to such components
- Received live vaccination within 30 days
- Severe cardiovascular disease within 6 months prior to screening
- Pregnant or lactating women
- History of asthma or severe allergies
- Unlikely to complete study visits or comply with protocol
- Other investigator-determined reasons for unsuitability
- Disease-specific exclusions including neuropsychiatric lupus, liver cirrhosis, aplastic anemia, uncontrolled myasthenic crisis, severe pulmonary hypertension, advanced kidney disease, drug-induced myositis, cancer-associated myositis, and others as specified
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Boren Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yajing Zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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