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MRNA therapy takes on autoimmune diseases in early trial

NCT ID NCT06747156

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new mRNA-based treatment (ABO2203) for people with autoimmune diseases that haven't improved with standard care. The therapy works by directing the body's immune cells to attack and control overactive immune cells causing the disease. The study will enroll 66 adults to check safety and early signs of effectiveness.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 66 people

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

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. ≥18 years of age at time of informed consent. 2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria. 3. Inadequate response to SoCs or relapsed after the treatment. 4. Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment. 5. Sufficient organ function. Exclusion Criteria: 1. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc. 2. Severe hypogammaglobulinemia or IgA deficiency. 3. Active hepatitis or with a history of severe liver disease. 4. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids. 5. Severe cardiovascular diseases. 6. History of cancer within past 5 years. 7. Have other serious medical conditions. 8. Received any of B cell targeted therapies and biologic therapies within the defined time window. 9. History of severe allergies or known allergies to any active or inactive component of the study drug(s). 10. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.

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Conditions

The condition(s) this trial relates to.

autoimmune disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Ruijin Hospital

    RECRUITING

    Shanghai, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

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