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MRNA technology takes on autoimmune diseases in early trial

NCT ID NCT07388212

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new mRNA drug that targets two proteins (CD19 and BCMA) on immune cells. The goal is to clear the faulty B cells and plasma cells that attack the body in autoimmune diseases. 27 adults aged 18-70 with relapsed or hard-to-treat autoimmune diseases will receive the drug to see if it is safe and can help control their condition.

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 27 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

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 to 70 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: * 1\. Age range of 18-70 years old (including threshold), gender not limited; * 2\. KPS score\>60 points, life expectancy greater than 6 months; * 3\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel; * 4\. Those who can understand this experiment and have signed the informed consent form; * 5\. Before screening (at baseline), corresponding conditions should be met; * 6\. Disease related inclusion criteria (study participants must meet one of the following disease criteria): Indications for recurrent or refractory autoimmune diseases, including but not limited to systemic lupus erythematosus (SLE), etc. Exclusion Criteria: * 1\. Study participants who are allergic or hypersensitive to any component of the investigational drug, including those who are allergic to messenger RNA (mRNA) vaccines or other RNA LNP products. * 2\. Merge any active infections that require antibiotic treatment and have not been controlled for at least one week prior to administration. * 3\. Accompanied by other uncontrolled malignant tumors. * 4\. History of cardiovascular disease within the first 6 months of screening: NYHA defined grade III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases. * 5\. Positive for hepatitis B surface antigen (HBsAg); Or those who are positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus (HBV) DNA or have a titer higher than the detection threshold; Individuals with positive hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; Human immunodeficiency virus (HIV) antibody positive individuals; Cytomegalovirus (CMV) DNA positive or above the detection limit; Individuals who are positive for syphilis antigen or antibody. * 6\. Have received attenuated live vaccine or protein subunit vaccine within 30 days before the first study medication. * 7\. Women who are currently pregnant, breastfeeding, or planning to become pregnant. * 8\. The researchers believe that there are other situations that are not suitable for participating in this clinical study.

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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

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  1. The official record

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More trials for these conditions

Other studies related to the condition(s) this trial covers.