MRNA technology takes on autoimmune diseases in new trial
NCT ID NCT07362758
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 47 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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14 to 70 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.
Show the full entry requirements Hide 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
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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.
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