Could a single injection reprogram immune cells to tame lupus and scleroderma?
NCT ID NCT07523282
First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This early study tests a new drug called HN2302, which aims to create CAR-T cells inside the body to target and control autoimmune diseases like lupus and scleroderma. The trial will enroll 12 adults to check safety and see if the treatment works. It is a first step, so results will show whether the approach is safe enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HN2302 (in vivo CAR-T therapy)
- What this could lead to
- If it works, this could point toward a new way to control autoimmune diseases like lupus and scleroderma without needing lifelong medication.
- What could go wrong
- This is a very early, small Phase 1 trial with only 12 people. It is designed mainly to check safety, not yet to prove it works. There may be side effects or it may not help at all.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036, China
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Other studies related to the condition(s) this trial covers.
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