Autoimmune DiseasePhase 1AIDNCT07523282
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
A Phase 1 study testing HN2302 Injection in people with Autoimmune Disease and Systemic Lupus Erythematosus, run by Shenzhen MagicRNA Biotechnology Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
- What is being tested?
- HN2302 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036
About this study
Official title: 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).
Read the 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.
- Being tested
- HN2302 Injection
- Keywords
- SLE, SSc
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HN2302 InjectionDrug
Also called in vivo CAR-T
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.
| Study group | Role | What they receive |
|---|---|---|
| HN2302 treatment group | Experimental | Participants will receive HN2302 Injection at the specified dose level and on the specified study days. Receives: Drug: HN2302 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
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.
Measured: 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).
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Responsible party
- Sponsor
- Investigators
- Zhu Chen, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523282
- Sponsor's protocol ID
- HN2302-N01
- Acronym
- AID
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07523282
- Acronym / sponsor ID
- AID / HN2302-N01
- Keywords
- SLE, SSc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shenzhen MagicRNA Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HN2302 treatment group | Experimental | Drug: HN2302 InjectionParticipants will receive HN2302 Injection at the specified dose level and on the specified study days. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HN2302 InjectionAlso: in vivo CAR-TDosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol. | Drug | HN2302 treatment group |
Primary outcome
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.
12 secondary outcomes
in vivo CAR T cell production
Time frame: Up to14 days
B-cell proportion and absolute count in peripheral blood
Time frame: Up to 12 months
Change from baseline in SLEDAI-2K score
Time frame: Up to 12 months
Change from baseline in Physician Global Assessment (PGA)
Time frame: Up to 12 months
Proportion of participants achieving lupus low disease activity status (LLDAS)
Time frame: Up to 12 months
Proportion of patients achieving DORIS remission
Time frame: Up to 12 months
Proportion of participants achieving SRI-4 response
Time frame: Up to 12 months
Changes from baseline in Patient Global Assessment （PtGA）
Time frame: Up to 12 months
Change from baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) index
Time frame: Up to 12 months
Change from baseline in modified Rodnan Skin Score (mRSS)
Time frame: Up to 12 months
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Up to 12 months
Change from baseline in revised Composite Response Index in Systemic Sclerosis (r-CRISS) score
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhu Chen principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HN2302 Injection in people with Autoimmune Disease and Systemic Lupus Erythematosus, run by Shenzhen MagicRNA Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu Chen (+86055162284920, doczchen@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.