A Phase 1 interventional study of HN2302 Injection in Autoimmune Disease, Systemic Lupus Erythematosus and Systemic Sclerosis (SSc), sponsored by Shenzhen MagicRNA Biotechnology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Shenzhen MagicRNA Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment
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).
The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 12 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Shenzhen MagicRNA Biotechnology Co., Ltd is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Compared within Lupus Erythematosus, Systemic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autoimmune Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: in vivo CAR-T
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.
Time frame: Up to 3 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic →
Shenzhen MagicRNA Biotechnology Co., Ltd