Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases (AID)

A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus; Autoimmune Disease; Systemic Sclerosis (SSc)
• Intervention / Treatment: Drug: HN2302 Injection

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhu Chen; Phone Number: +86055162284920; Email: doczchen@ustc.edu.cn
• Study Contact Backup: Name: Zexiu Xiao; Phone Number: +86075527109036; Email: xiaozexiu@magicrna.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230036
      • The First Affiliated Hospital of University of Science and Technology of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HN2302 treatment group; Participants will receive HN2302 Injection at the specified dose level and on the specified study days.	Drug: HN2302 Injection; Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.; Other Names: in vivo CAR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Incidence, nature, and severity of treatment-emergent adverse events, assessed according to the study protocol and applicable toxicity grading criteria.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in modified Rodnan Skin Score (mRSS)	Assessment of change from baseline in modified Rodnan Skin Score (mRSS). Total scores range from 0 to 51, with higher scores indicating greater skin thickening.	Up to 12 months
in vivo CAR T cell production	Assessment of in vivo CAR-T cell production, defined by the proportion of CAR-expressing T cells in peripheral blood as measured by flow cytometry.	Up to14 days
B-cell proportion and absolute count in peripheral blood	Assessment of peripheral blood B-cell proportion, absolute B-cell count (cells/μL), and B-cell subsets, including naive B cells and memory B cells, by flow cytometry.	Up to 12 months
Change from baseline in SLEDAI-2K score	Assessment of change from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Total scores range from 0 to 105, with higher scores indicating greater disease activity.	Up to 12 months
Change from baseline in Physician Global Assessment (PGA)	Assessment of change from baseline in Physician Global Assessment (PGA) at scheduled visits through Month 12. Scores range from 0.0 to 3.0, with higher scores indicating greater disease activity.	Up to 12 months
Proportion of participants achieving lupus low disease activity status (LLDAS)	Proportion of participants who achieve LLDAS at scheduled visits through Month 12	Up to 12 months
Proportion of patients achieving DORIS remission	Proportion of participants who achieve Definitions of Remission in SLE (DORIS) remission at scheduled visits through Month 12.	Up to 12 months
Proportion of participants achieving SRI-4 response	Proportion of participants who meet the criteria for the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at scheduled visits through Month 12.	Up to 12 months
Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score	Assessment of change from baseline in the revised Composite Response Index in Systemic Sclerosis (r-CRISS), a weighted composite score based on 5 core measures of disease status, improved by a certain percentage in ≥3 of 5 core set measures.	Up to 12 months
Changes from baseline in Patient Global Assessment （PtGA）	Assessment of change from baseline in Patient Global Assessment (PtGA) of overall disease activity at scheduled visits through Month 12. Typically on a 0 to 10 numeric scale, where 0 indicates no disease activity and 10 represents the worst possible activity.	Up to 12 months
Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index	Assessment of change from baseline in the BILAG-2004 index. The BILAG-2004 index evaluates 97 clinical manifestations of SLE across 9 organ domains, with activity in each domain graded from A to E, the activity level of the disease respond to the score.	Up to 12 months
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	Assessment of change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), a patient-reported measure of functional ability across 8 domains, the patient responds on a scale of 0 (no disability) to 3 (completely disabled).	Up to 12 months

Collaborators and Investigators

• Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd
• Collaborators: The First Affiliated Hospital of University of Science and Technology of China
• Investigators: Principal Investigator: Zhu Chen, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SLE; SSc
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Scleroderma, Systemic
• Other Study ID Numbers: HN2302-N01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No