Evaluating HN2301 for treating difficult cases of systemic lupus erythematosus

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）

This study is testing if HN2301 injections can help adults with tough cases of lupus who haven't improved with regular treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06801119 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and initial efficacy of HN2301 injections in patients with relapsing and refractory systemic lupus erythematosus (SLE). It is a prospective exploratory trial that includes individuals aged 18 to 69 who have been diagnosed with SLE and have not responded adequately to standard treatments. Participants must have a history of SLE for at least six months and have been on a stable treatment regimen for at least eight weeks. The study will monitor the participants for safety and effectiveness of the new treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 69 with a confirmed diagnosis of systemic lupus erythematosus who have experienced relapses despite standard treatment.

Not a fit: Patients who have not been diagnosed with systemic lupus erythematosus or those who have not tried multiple immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with refractory systemic lupus erythematosus who have not responded to existing therapies.

How similar studies have performed: While this approach is exploratory, similar studies targeting refractory systemic lupus erythematosus have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Patients aged between 18 and 69 (inclusive), of any gender;
* 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;
* Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;
* 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; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg/day and ≤30mg/day. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-ds-DNA antibodies, and/or hypocomplementemia;
* 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.

Exclusion Criteria:

* 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;
* Pregnant or breastfeeding women;
* Receiving any mRNA-LNP product or other LNP medications within the past two years;
* 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;
* History of live vaccine administration within the last 30 days;
* Individuals with asthma, severe allergies;
* Other conditions deemed inappropriate for participation in this clinical study by the investigator.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Zhu Chen, MD — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Zhu Chen, MD

Conditions Systemic Lupus Erythematosus; Scleroderma; Rheumatoid Arthritis; SLE, SSc,RA