Clinical Study of AFN50 Injection in the Autoimmune Diseases

NCT07408336 | Recruiting Early Phase 1

• 1 other identifier: PJ-2025-12-57
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated trial designed to evaluate the safety, tolerability and primary efficacy of AFN50 injection for the treatment of autoimmune diseases.

Conditions

Autoimmune Diseases

Keywords

AFN50; SLE

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of AEs associated with AFN50 as assessed by CTCAE v5.0

  3 months

Secondary Outcomes (8)

• in vivo CAR T cell production

  Day-28 to 28 days

• B cell ratios and counts in peripheral blood

  Day-28 to 12 months

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

  Day-28 to12 months

• SLE Responder Index-4 (SRI-4)

  Day-28 to12 months

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

  Day-28 to12 months

Study Arms (1)

Participant Group

EXPERIMENTAL

AFN50 Injection

Biological: AFN50 injection

Interventions

AFN50 injection BIOLOGICAL

Intravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) encapsulating mRNA encoding Chimeric Antigen Receptor.

Participant Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and voluntarily sign the written informed consent form;
• Patients aged between 18 and 69 (inclusive), of any gender, diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria;
• A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks, with the dosage stable for 2 weeks, yet the disease remains active or has relapsed; Standard treatment refers to the stable use of the following drugs alone or in combination: non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, corticosteroids; 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);
• Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg/day and ≤30mg/day. If used in combination with immunosuppressants, there is no minimum daily dose requirement;
• Standardized treatment failure with hydroxychloroquine or at least two immunosuppressants;
• Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or hypocomplementemia (low C3 and/or C4);
• Screening period SLEDAI-2K score ≥6 points. If scoring includes low complement and/or anti-ds-DNA antibodies, the score for SLEDAI-2K clinical symptoms (excluding low complement and/or anti-ds-DNA antibodies) should be ≥4 points;
• Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions.
• Coagulation function: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5 times the upper limit of normal (ULN).
• Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥40% as measured by echocardiography (ECHO).
• Pulmonary function: Dyspnea of ≤CTCAE Grade 1; pulse oxygen saturation (SpO2) \>92% under room air.
• Hepatic function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN; total bilirubin ≤1.5×ULN.
• Renal function: Creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥50 mL/min, without the need for fluid support;
• Baseline oxygen saturation \>92% without oxygen supplementation;
• Non-pregnant/non-lactating participants. Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or postmenopausal women for at least 2 years are not considered women of childbearing potential) and be willing to adopt contraceptive measures within 12 months after drug infusion.

You may not qualify if:

• Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;
• Presence of other uncontrolled active infections;
• History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
• Receiving any mRNA-LNP product or other LNP medications within the past two years, and with a history of allergy to LNP and its components;
• History of live vaccine administration within the last 30 days;
• History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac diseases;
• Pregnant or breastfeeding women;
• Individuals with asthma, severe allergies;
• In the investigator's judgment, the participate is unlikely to complete all protocol-required study visits or procedures, including follow-up visits or adherence to the study participation requirements.
• Other conditions deemed inappropriate for participation in this clinical study by the investigator.

Sponsors & Collaborators

• AlphaNa Bioscience Company Limited: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Beicheng SUN, Dr

CONTACT

+86 551 6292 2800; sunbc0207@163.com

Huan ZHOU, Dr

CONTACT

+8613665527160; zhouhuanbest@vip.163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 13, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): February 3, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)