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Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） | Clinical Trials | Clareo Health

RECRUITINGNA

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）

NCT06801119•Shenzhen MagicRNA Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This is an investigator-initiated trial designed to evaluate the safety, and efficacy of HN2301 in Autoimmune Disease（AID）

Detailed Description

This study is a prospective exploratory clinical trial in subjects with Autoimmune Disease（SLE, SSc, RA, etc.）. The objective is to evaluate the safety, initial efficacy of HN2301 injection in Autoimmune Disease（SLE, SSc, RA, etc..

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients aged between 18 and 69 (inclusive), of any gender, diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria;
•2. A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks, with the dosage stabilized 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 cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, etc.; targeted drugs include belimumab, rituxima, eculizumab, rituximab, etc.
•3. 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;
•4. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine);
•5. Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-ds-DNA antibodies, and/or hypocomplementemia;
•6. 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; SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score; RA-meets the classification criteria of ACR and EULAR, DAS28-ESR\>3.2, ACPA possitive.
•7. Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\^9/L, ALC ≥0.8×10\^9/L, Hb ≥80g/L. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin \<2.0mg/dL (Gilbert syndrome subjects total bilirubin \<3.0mg/dL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL/min without need for fluid assistance;
•8. Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion.

Exclusion Criteria

•1. 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;
•2. Presence of other uncontrolled active infections;
•3. History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
•4. Pregnant or breastfeeding women;
•5. Receiving any mRNA-LNP product or other LNP medications within the past two years;
•6. 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;
•7. History of live vaccine administration within the last 30 days;
•8. Individuals with asthma, severe allergies;
•9. Other conditions deemed inappropriate for participation in this clinical study by the investigator.

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Key Dates

Start Date

March 16, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus ErythematosusSclerodermaRheumatoid Arthritis

Interventions

HN2301 injection

DRUG

Contacts

Zhu Chen, MD

CONTACT

+86055162284920 doczchen@ustc.edu.cn

Ze Xiu Xiao, MD

CONTACT

+86075527109036 xiaozexiu@magicrna.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

Inclusion Criteria

Exclusion Criteria

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