Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

NCT07523282 | Not Yet Recruiting Phase 1

• 1 other identifier: HN2302-N01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Sclerosis (SSc); Autoimmune Disease; Systemic Lupus Erythematosus

Keywords

SLE; SSc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Study Arms (1)

HN2302 treatment group

EXPERIMENTAL

Participants will receive HN2302 Injection at the specified dose level and on the specified study days.

Drug: HN2302 Injection

Interventions

HN2302 Injection DRUG

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.

Also known as: in vivo CAR-T

HN2302 treatment group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen MagicRNA Biotechnology Co., Ltd: lead
• The First Affiliated Hospital of University of Science and Technology of China: collaborator

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230036, China

Location

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Zhu Chen

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu Chen

CONTACT

+86055162284920; doczchen@ustc.edu.cn

Zexiu Xiao

CONTACT

+86075527109036; xiaozexiu@magicrna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)