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Could a single injection reprogram immune cells to tame lupus and scleroderma?

NCT ID NCT07523282

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.