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MRNA technology takes on autoimmune diseases in new trial

NCT ID NCT07362758

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 therapy that targets CD19, a protein on immune cells, to treat autoimmune diseases like lupus and immune anemia. The treatment uses lipid nanoparticles to deliver mRNA that helps the body clear harmful B cells. About 47 participants aged 14-70 with difficult-to-treat autoimmune conditions will be enrolled to find the safest dose and see if it controls the disease.

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 47 people

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

Expected to start

Jan 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

14 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 14-70 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\. Indications for severe, recurrent, or refractory immune related diseases, including immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), systemic lupus erythematosus(SLE),systemic sclerosis (SSc) etc., meet the corresponding inclusion criteria; For other types of diseases, researchers will assess whether they meet the inclusion requirements after fully evaluating the risks and benefits based on the patient's treatment needs. 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 D1 administration. * 3\) Malignant tumors diagnosed within the first 2 years of screening are excluded, except for skin basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ that has been adequately treated. * 4\) Uncontrolled ischemic heart disease, including unstable angina within the previous 6 months of screening, or evidence of active ischemic heart disease on electrocardiogram. * 5\) New York Heart Association (NYHA) grade III-IV heart failure. * 6\) Study participants with combined active hepatitis B virus (HBV) infection \[defined as surface antigen (HBsAg) positive and HBV DNA positive (detected by PCR)\]. * 7\) Study participants with combined active hepatitis C virus (HCV) infection (defined as HCV RNA positive (detected by PCR), regardless of anti HCV antibody status). * 8\) Human immunodeficiency virus (HIV) infection or history of HIV infection. * 9\) Study participants who tested positive for Treponema pallidum specific antibodies. * 10\) There may be active infection of Mycobacterium tuberculosis. * 11\) Women who are currently pregnant, breastfeeding, or planning to become pregnant. * 12\) Combining severe or recently (\<2 months) diagnosed medical conditions, as determined by the researchers, may affect the study participants' tolerance to the study drug or their ability to complete the study process. * 13\) Received attenuated live vaccine or protein subunit vaccine within 30 days prior to the first study medication.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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