NCT07523282Not yet recruitingPhase 1
A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
Shenzhen MagicRNA Biotechnology Co., Ltd1 site in 1 country12 target enrollmentStarted: December 31, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
Study Overview
Brief Summary
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).
Detailed Description
The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.
Exclusion Criteria
- •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.
- •Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.
- •History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.
- •Receipt of a live vaccine within 30 days before screening.
- •History of asthma or severe allergy, if considered clinically significant by the investigator.
- •Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.
Arms & Interventions
HN2302 treatment group
Experimental
Participants will receive HN2302 Injection at the specified dose level and on the specified study days.
Intervention: HN2302 Injection (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 3 months
Incidence, nature, and severity of treatment-emergent adverse events, assessed according to the study protocol and applicable toxicity grading criteria.
Secondary Outcomes
- in vivo CAR T cell production(Up to14 days)
- B-cell proportion and absolute count in peripheral blood(Up to 12 months)
- Change from baseline in SLEDAI-2K score(Up to 12 months)
- Change from baseline in Physician Global Assessment (PGA)(Up to 12 months)
- Proportion of participants achieving lupus low disease activity status (LLDAS)(Up to 12 months)
- Proportion of patients achieving DORIS remission(Up to 12 months)
- Proportion of participants achieving SRI-4 response(Up to 12 months)
- Changes from baseline in Patient Global Assessment （PtGA）(Up to 12 months)
- Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index(Up to 12 months)
- Change from baseline in modified Rodnan Skin Score (mRSS)(Up to 12 months)
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to 12 months)
- Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score(Up to 12 months)
Investigators
Study Sites (1)
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