Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-69
SponsorShenzhen MagicRNA Biotechnology Co., Ltd
About this trial
This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
Eligibility criteria
Qualifiers
Adults aged 18 to 69 years, regardless of gender.
Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.
Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.
Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and/or positive anti-double-stranded DNA antibody, and/or hypocomplementemia.
Disqualifiers
Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.
Presence of any other uncontrolled active infection.
History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow/hematopoietic stem cell transplantation.
Pregnant or breastfeeding women.
Trial design
Treatments tested in this trial
- HN2302 Injection
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Shenzhen MagicRNA Biotechnology Co., Ltd
Lead sponsor
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
Source ClinicalTrials.gov