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

Launched by SHENZHEN MAGICRNA BIOTECHNOLOGY CO., LTD · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called HN2301 for patients with systemic lupus erythematosus (SLE) who have not responded well to standard treatments. The goal is to determine how safe and effective HN2301 is for people whose lupus symptoms are still active or have returned despite using other medications. The trial is currently looking for participants aged 18 to 69, of any gender, who have been diagnosed with SLE and have been on stable treatments for at least eight weeks but continue to experience active symptoms.

If you decide to participate, you will undergo regular health assessments to ensure you meet specific criteria, such as having certain blood test results and functioning organs. Participants will receive HN2301 and will be monitored closely for any side effects and improvements in their symptoms. It’s important to note that there are some conditions that would exclude you from participating, such as having certain infections, being pregnant or breastfeeding, or having recently received specific other treatments. This trial aims to provide new hope for those struggling with lupus that hasn’t responded to existing therapies.

Gender

ALL

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.