Efficacy and Safety of HN2301 in Refractory Systemic Lupus Erythematosus (SLE)

NCT ID: NCT06801119

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-16
• Study Completion Date: 2026-03-31

Brief Summary

This is an investigator-initiated trial designed to evaluate the safety, and efficacy of HN2301 in Relapsing and refractory systemic lupus erythematosus

Detailed Description

This study is a prospective exploratory clinical trial in subjects with Relapsing and refractory systemic lupus erythematosus. The objective is to evaluate the safety, initial efficacy of HN2301injection in Relapsing and refractory systemic lupus erythematosus

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HN2301 treatment group

Group Type: EXPERIMENTAL

HN2301 injection

Intervention Type: DRUG

Three dose groups were set up, starting from the low dose group and climbing to explore the safe and effective dose.

Interventions

HN2301 injection

Three dose groups were set up, starting from the low dose group and climbing to explore the safe and effective dose.

Intervention Type: DRUG

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Shenzhen MagicRNA Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu Chen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hefei, Anhui, China

Site Status: NOT_YET_RECRUITING

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

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhu Chen, MD

Role: CONTACT

doczchen@ustc.edu.cn

+86055162284920

Ze Xiu Xiao, MD

Role: CONTACT

xiaozexiu@magicrna.com

+86075527109036

Facility Contacts

Zhu Chen, MD

Role: primary

doczchen@ustc.edu.cn

+86055162284920

Chen Head, MD

Role: primary

doczchen@ustc.cn

+86055162284920

Xiao Head, MD

Role: backup

xiaozexiu@magicrna.com

+86075527109036

Other Identifiers

HN2301-001

Identifier Type: -

Identifier Source: org_study_id