NCT06801119 Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
| NCT ID | NCT06801119 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen MagicRNA Biotechnology Co., Ltd |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
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.
Contact & Investigator
Zhu Chen, MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT06801119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06801119 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06801119 currently recruiting?
Yes, NCT06801119 is actively recruiting participants. Contact the research team at doczchen@ustc.edu.cn for enrollment information.
Where is the NCT06801119 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06801119 clinical trial?
NCT06801119 is sponsored by Shenzhen MagicRNA Biotechnology Co., Ltd. The principal investigator is Zhu Chen, MD at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 30 participants.
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