New mRNA shot aims to calm stubborn autoimmune diseases
NCT ID NCT07349823
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug called WGb-0301 for people with autoimmune diseases (like lupus or autoimmune hepatitis) that haven't responded to standard treatments. The drug uses mRNA technology to target and clear certain immune cells (B cells) that are causing the disease. The main goals are to find a safe dose and see if it can control the disease long-term.
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
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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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18 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 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 requirements should be met; * 6\. Diagnosed with recurrent or refractory immune related diseases, including systemic lupus erythematosus (SLE), autoimmune hepatitis, idiopathic inflammatory myopathy, scleroderma, 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\. New York Heart Association (NYHA) grade III-IV heart failure. * 6\. Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) DNA positive or 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. * 7\. Vaccination with attenuated live vaccine or protein subunit vaccine within 30 days prior to the first study use. * 8\. Women who are currently pregnant, breastfeeding, or planning to become pregnant. * 9\. 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
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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