Systemic Lupus ErythematosusPhase 1SLE，SSc，RANCT06801119
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
A Phase 1 study testing HN2301 injection in people with Systemic Lupus Erythematosus and Scleroderma, run by Shenzhen MagicRNA Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID） Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Scleroderma, Rheumatoid Arthritis
- What is being tested?
- HN2301 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2025to 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
- Patients aged between 18 and 69 (inclusive), of any gender;
- Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10^9/L, ALC ≥0.8×10^9/L, Hb ≥80g/L. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin <2.0mg/dL (Gilbert syndrome subjects total bilirubin <3.0mg/dL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL/min without need for fluid assistance;
- Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg/day and ≤30mg/day. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-ds-DNA antibodies, and/or hypocomplementemia;
- SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;
- RA-meets the classification criteria of ACR and EULAR, DAS28-ESR>3.2, ACPA possitive.
Who cannot join
- Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;
- Presence of other uncontrolled active infections;
- History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
- Pregnant or breastfeeding women;
- Receiving any mRNA-LNP product or other LNP medications within the past two years;
- History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac diseases;
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- History of live vaccine administration within the last 30 days;
- Individuals with asthma, severe allergies;
- Other conditions deemed inappropriate for participation in this clinical study by the investigator.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Zhu Chen, MD, +86055162284920, doczchen@ustc.edu.cn
About this study
Official title: Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
Read the detailed description
This study is a prospective exploratory clinical trial in subjects with Autoimmune Disease（SLE, SSc, RA, etc.）. The objective is to evaluate the safety and efficacy of HN2301 injection in Autoimmune Disease (SLE, SSc, RA, etc.).
- Being tested
- HN2301 injection
- Keywords
- SLE, SSc,RA
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Diffuse, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HN2301 injectionDrug
Also called in vivo cart
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 |
|---|---|---|
| HN2301 treatment group | Experimental | Participants will receive HN2301 Injection at the specified dose level and on the specified study days. Receives: Drug: HN2301 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 (14)
vivo CAR T cell production
CAR T production in the peripheral blood of AID patients, by flow cytometry (FACS), and quantitative polymerase chain reaction (qPCR) in peripheral blood
Measured: Day-28 to14 days
B cell ratio and counts in peripheral blood
Assessment of B cell ratio and counts (B cell counts per μl peripheral blood) and B cell subsets(naive B cell, memory B cell) by flow cytometry (FACS) in peripheral blood
Measured: Day-28 to12 months
Change from baseline of SLEDAI-2K score after HN2301 administration.
Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow-up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Measured: Day-28 to12 months
Quantify the clinical activity of HN2301 in patients using Physician Global Assessment (PGA) .
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity.
Measured: Day-28 to12 months
Proportion of participants achieving lupus low disease activity status (LLDAS)
Proportion of participants who achieve LLDAS at scheduled visits through Month 12.
Measured: Day-28 to12 months
Proportion of patients achieving DORIS remission after HN2301 administration
Assessment of DORIS response rate at various timepoints up to the month 12 follow-up visit.
Measured: Day-28 to12 months
Assess the clinical activity of HN2301 in patients with SLE using Systemic Lupus Erythematosus Responder Index-4 (SRI-4)
Assessment of whether participants meet the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) criteria (yes/no) at various timepoints up to the month 12 follow-up visit.
Measured: Day-28 to12 months
Proportion of patients achieving complete renal response (CRR) after HN2301 administration
Proportion of patients achieving complete renal response (CRR) after HN2301 administration
Measured: Day-28 to12 months
Changes from baseline in Patient Global Assessment（PtGA） scores
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 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
Changes from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score
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
Changes from baseline in Disease Activity Score (DAS28) score
Proportion of patients disease activity changes, a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity.
Measured: Up to 12 months
Changes from baseline in Visual Analogue Scale (VAS) score
A total score can fall between 0 and 10
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 posted30 Jan 2025
- Study start16 Mar 2025
- 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 Systemic Lupus ErythematosusStudies 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
- 30 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, MD, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801119
- Sponsor's protocol ID
- HN2301-N01
- Acronym
- SLE，SSc，RA
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2025
- 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
- Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）
- ClinicalTrials.gov ID
- NCT06801119
- Acronym / sponsor ID
- SLE，SSc，RA / HN2301-N01
- Keywords
- SLE, SSc,RA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 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
- 16 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Jan 2025 (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 lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
Detailed description
This study is a prospective exploratory clinical trial in subjects with Autoimmune Disease（SLE, SSc, RA, etc.）. The objective is to evaluate the safety and efficacy of HN2301 injection in Autoimmune Disease (SLE, SSc, RA, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HN2301 treatment group | Experimental | Drug: HN2301 injectionParticipants will receive HN2301 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 (6 listed)
- Patients aged between 18 and 69 (inclusive), of any gender;
- Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10^9/L, ALC ≥0.8×10^9/L, Hb ≥80g/L. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin <2.0mg/dL (Gilbert syndrome subjects total bilirubin <3.0mg/dL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL/min without need for fluid assistance;
- Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg/day and ≤30mg/day. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and/or positive anti-ds-DNA antibodies, and/or hypocomplementemia;
- SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;
Key exclusion criteria (9 listed)
- Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;
- Presence of other uncontrolled active infections;
- History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
- Pregnant or breastfeeding women;
- Receiving any mRNA-LNP product or other LNP medications within the past two 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 |
|---|---|---|
| HN2301 injectionAlso: in vivo cartDosing 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 | HN2301 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.
14 secondary outcomes
vivo CAR T cell production
Time frame: Day-28 to14 days
B cell ratio and counts in peripheral blood
Time frame: Day-28 to12 months
Change from baseline of SLEDAI-2K score after HN2301 administration.
Time frame: Day-28 to12 months
Quantify the clinical activity of HN2301 in patients using Physician Global Assessment (PGA) .
Time frame: Day-28 to12 months
Proportion of participants achieving lupus low disease activity status (LLDAS)
Time frame: Day-28 to12 months
Proportion of patients achieving DORIS remission after HN2301 administration
Time frame: Day-28 to12 months
Assess the clinical activity of HN2301 in patients with SLE using Systemic Lupus Erythematosus Responder Index-4 (SRI-4)
Time frame: Day-28 to12 months
Proportion of patients achieving complete renal response (CRR) after HN2301 administration
Time frame: Day-28 to12 months
Changes from baseline in Patient Global Assessment（PtGA） scores
Time frame: Up to 12 months
Change from baseline in modified Rodnan Skin Score (mRSS)
Time frame: Up to 12 months
Changes from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score
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
Changes from baseline in Disease Activity Score (DAS28) score
Time frame: Up to 12 months
Changes from baseline in Visual Analogue Scale (VAS) 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, MD 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 HN2301 injection in people with Systemic Lupus Erythematosus and Scleroderma, 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 6 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: looking for participants now, 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, MD (+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.