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NCT Number: NCT07523282

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).

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Key information

Conditions

Autoimmune Disease Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Systemic Sclerosis (SSc)

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Hefei, Anhui, 230036, China

About this study

The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: in vivo CAR-T

Primary outcomes

  1. 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

  1. in vivo CAR T cell production

    Time frame: Up to14 days

    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.

  2. B-cell proportion and absolute count in peripheral blood

    Time frame: Up to 12 months

    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.

  3. Change from baseline in SLEDAI-2K score

    Time frame: Up to 12 months

    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.

  4. Change from baseline in Physician Global Assessment (PGA)

    Time frame: Up to 12 months

    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.

  5. Proportion of participants achieving lupus low disease activity status (LLDAS)

    Time frame: Up to 12 months

    Proportion of participants who achieve LLDAS at scheduled visits through Month 12

  6. Proportion of patients achieving DORIS remission

    Time frame: Up to 12 months

    Proportion of participants who achieve Definitions of Remission in SLE (DORIS) remission at scheduled visits through Month 12.

  7. Proportion of participants achieving SRI-4 response

    Time frame: Up to 12 months

    Proportion of participants who meet the criteria for the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at scheduled visits through Month 12.

  8. Changes from baseline in Patient Global Assessment （PtGA）

    Time frame: Up to 12 months

    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.

  9. Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index

    Time frame: Up to 12 months

    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.

  10. Change from baseline in modified Rodnan Skin Score (mRSS)

    Time frame: Up to 12 months

    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.

  11. Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Up to 12 months

    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).

  12. Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score

    Time frame: Up to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zexiu Xiao

CONTACT

[email protected]

+86075527109036

Zhu Chen

CONTACT

[email protected]

+86055162284920

Sponsors and collaborators

Lead sponsor

Shenzhen MagicRNA Biotechnology Co., Ltd

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: AID

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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