Autoimmune DiseasesEarly Phase 1NCT07408336
Clinical Study of AFN50 Injection in the Autoimmune Diseases
A Early Phase 1 study testing AFN50 injection in people with Autoimmune Diseases, run by AlphaNa Bioscience Company Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2026to 3 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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);
Show all 16Show fewer
- 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.
- Bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L (no granulocyte colony-stimulating factor (G-CSF) administered within 7 days prior to screening; a 14-day interval required for long-acting G-CSF); Hemoglobin (Hb) ≥80 g/L (no red blood cell transfusion within 14 days prior to screening; recombinant human erythropoietin is permitted. For patients meeting the Hb ≥80 g/L inclusion criterion, red blood cell transfusion is allowed during treatment to maintain hemoglobin level at ≥80 g/L); Platelet Count (PLT) ≥50×10⁹/L, Absolute Lymphocyte Count (ALC) ≥0.8×10⁹/L.
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Huan Zhou, PhD, +86 055162922800, zhouhuanbest@vip.163.com
Beichen Sun, PhD
About this study
This is an investigator-initiated trial designed to evaluate the safety, tolerability and primary efficacy of AFN50 injection for the treatment of autoimmune diseases.
Read the detailed description
This study is a prospective exploratory clinical trial in subjects with autoimmune diseases, mainly relapsing and refractory systemic lupus erythematosus. The objective is to evaluate the safety, tolerability, and primary efficacy of AFN50 injection in relapsing and refractory systemic lupus erythematosus.
- Conditions
- Autoimmune Diseases
- Being tested
- AFN50 injection
- Keywords
- AFN50, SLE
- 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) encapsulating mRNA encoding Chimeric Antigen Receptor.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | AFN50 Injection Receives: Biological: AFN50 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of AEs associated with AFN50 as assessed by CTCAE v5.0
Measured: 3 months
Secondary outcomes (8)
in vivo CAR T cell production
The counts, proportions and sustained days of CAR-T cells in the peripheral blood
Measured: Day-28 to 28 days
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
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 to12 months
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
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
Proportion of participants achieving DORIS remission
Proportion of participants achieving DORIS (Definition Of Remission In SLE) remission after AFN50 administration.
Measured: Day-28 to12 months
Proportion of participants achieving complete renal response (CRR)
Proportion of participants achieving complete renal response (CRR) after AFN50 administration
Measured: Day-28 to12 months
Proportion of participants achieving low disease activity status (LLDAS)
Maintenance of LLDAS: The proportion of participants with SLE who remain in Lupus Low Disease Activity State at predefined study visits through the 12-month follow-up period.
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.
- First posted13 Feb 2026
- Study start4 Feb 2026 (estimated)
- Primary completion4 Feb 2028 (estimated)
- Study completion3 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlphaNa Bioscience Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408336
- Sponsor's protocol ID
- PJ-2025-12-57
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of AFN50 Injection in the Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07408336
- Acronym / sponsor ID
- PJ-2025-12-57
- Conditions
- Autoimmune Diseases
- Keywords
- AFN50, SLE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- AlphaNa Bioscience Company LimitedUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- 4 Feb 2026 (estimated)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 3 Feb 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated trial designed to evaluate the safety, tolerability and primary efficacy of AFN50 injection for the treatment of autoimmune diseases.
Detailed description
This study is a prospective exploratory clinical trial in subjects with autoimmune diseases, mainly relapsing and refractory systemic lupus erythematosus. The objective is to evaluate the safety, tolerability, and primary efficacy of AFN50 injection in relapsing and refractory systemic lupus erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Biological: AFN50 injectionAFN50 Injection |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFN50 injectionIntravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) encapsulating mRNA encoding Chimeric Antigen Receptor. | Biological | Participant Group |
Primary outcome
Adverse events
Time frame: 3 months
Incidence and severity of AEs associated with AFN50 as assessed by CTCAE v5.0
8 secondary outcomes
in vivo CAR T cell production
Time frame: Day-28 to 28 days
B cell ratios and counts in peripheral blood
Time frame: Day-28 to 12 months
Changes in the 2000 Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) relative to baseline in participants
Time frame: Day-28 to12 months
SLE Responder Index-4 (SRI-4)
Time frame: Day-28 to12 months
Changes in the Physician's Global Assessment (PGA) relative to baseline
Time frame: Day-28 to12 months
Proportion of participants achieving DORIS remission
Time frame: Day-28 to12 months
Proportion of participants achieving complete renal response (CRR)
Time frame: Day-28 to12 months
Proportion of participants achieving low disease activity status (LLDAS)
Time frame: Day-28 to12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AFN50 injection in people with Autoimmune Diseases, run by AlphaNa Bioscience Company Limited 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 16 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beicheng SUN, Dr (+86 551 6292 2800, sunbc0207@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (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 5 Mar 2026.