Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
| Condition(s) | Systemic Lupus Erythematosus, Scleroderma, Rheumatoid Arthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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） |
| Who can participate | 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) ≥5 |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Lead sponsor | Shenzhen MagicRNA Biotechnology Co., Ltd |
| Locations | Hefei, Anhui, China |
| Start date | 2025-03-16 |
| NCT ID | NCT06801119 |
| Official listing | https://clinicaltrials.gov/study/NCT06801119 |