Autoimmune DiseasesEarly Phase 1NCT07349823
Exploratory Study on the Treatment of Relapsed and Refractory Immune Related Diseases With WGb-0301 Injection
A Early Phase 1 study testing WGb-0301 injection in people with Autoimmune Diseases, run by West China Hospital.
Trial summary
The exact etiology and pathogenesis of immune related diseases (such as autoimmune hepatitis, systemic lupus erythematosus, etc.) have not been fully elucidated, and are generally believed to be the result of multiple factors such as genetics, environment, and immune regulation abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- WGb-0301 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
The exact etiology and pathogenesis of immune related diseases (such as autoimmune hepatitis, systemic lupus erythematosus, etc.) have not been fully elucidated, and are generally believed to be the result of multiple factors such as genetics, environment, and immune regulation abnormalities. The current standard treatment for immune related diseases includes corticosteroids, biologics (such as belimumab, rituximab), and immunosuppressants (such as mycophenolate mofetil, azathioprine, cyclophosphamide, etc.). Although hormones and traditional immunosuppressants can widely suppress immunity, there are risks of bone marrow suppression, liver and kidney function damage, and long-term malignant tumors. Some patients are ineffective with glucocorticoid therapy, and some patients relapse after discontinuation of medication. Although there are various treatment methods currently available, there are still many limitations to immune related diseases that aim for long-term remission, and further research and breakthroughs are urgently needed.
Research has shown that abnormal activation of B cells is one of the important mechanisms involved in the occurrence and development of immune related diseases. Therefore, therapeutic drugs targeting B cells, such as CD20 monoclonal antibodies, have been recommended by guidelines for the treatment of refractory and recurrent immune related diseases. The therapy targeting CD19, another B-cell target, has become an important research and development direction in the treatment of immune related diseases due to its ability to clear a wider range of B-cell lineages, including plasma cells and long-lived plasma cells, showing potential long-term remission effects.
The experimental drug WGb 0301 injection is a CD19 based messenger ribonucleic acid (mRNA) therapeutic drug, formed by loading mRNA encoding CD19 receptor related proteins onto lipid nanoparticles (LNP).
- Conditions
- Autoimmune Diseases
- Being tested
- WGb-0301 injection
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGb-0301 injectionDrug
Drug targeting CD19 based on mRNA-LNP
| Study group | Role | What they receive |
|---|---|---|
| WGb-0301 injection, Escalation doses | Experimental | Not described Receives: Drug: WGb-0301 injection |
| WGb-0301 injection, Extended doses | Experimental | Not described Receives: Drug: WGb-0301 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) and its incidence rate
Measured: Within 90 days after the initial treatment
Maxmum tolerated dose (MTD) or optimal biological dose (OBD)
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Preliminary efficacy evaluation: The degree and rate of remission of biochemical indicators
Measured: Through study completion, an average of 2 years
Preliminary efficacy evaluation: The degree and rate of remission of immunological indicators
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyan Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349823
- Sponsor's protocol ID
- 0301-IIT-ADs
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Treatment of Relapsed and Refractory Immune Related Diseases With WGb-0301 Injection
- ClinicalTrials.gov ID
- NCT07349823
- Acronym / sponsor ID
- 0301-IIT-ADs
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 26 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The exact etiology and pathogenesis of immune related diseases (such as autoimmune hepatitis, systemic lupus erythematosus, etc.) have not been fully elucidated, and are generally believed to be the result of multiple factors such as genetics, environment, and immune regulation abnormalities. The current standard treatment for immune related diseases includes corticosteroids, biologics (such as belimumab, rituximab), and immunosuppressants (such as mycophenolate mofetil, azathioprine, cyclophosphamide, etc.). Although hormones and traditional immunosuppressants can widely suppress immunity, there are risks of bone marrow suppression, liver and kidney function damage, and long-term malignant tumors. Some patients are ineffective with glucocorticoid therapy, and some patients relapse after discontinuation of medication. Although there are various treatment methods currently available, there are still many limitations to immune related diseases that aim for long-term remission, and further research and breakthroughs are urgently needed.
Research has shown that abnormal activation of B cells is one of the important mechanisms involved in the occurrence and development of immune related diseases. Therefore, therapeutic drugs targeting B cells, such as CD20 monoclonal antibodies, have been recommended by guidelines for the treatment of refractory and recurrent immune related diseases. The therapy targeting CD19, another B-cell target, has become an important research and development direction in the treatment of immune related diseases due to its ability to clear a wider range of B-cell lineages, including plasma cells and long-lived plasma cells, showing potential long-term remission effects.
The experimental drug WGb 0301 injection is a CD19 based messenger ribonucleic acid (mRNA) therapeutic drug, formed by loading mRNA encoding CD19 receptor related proteins onto lipid nanoparticles (LNP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WGb-0301 injection, Escalation doses | Experimental | Drug: WGb-0301 injection |
| WGb-0301 injection, Extended doses | Experimental | Drug: WGb-0301 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WGb-0301 injectionDrug targeting CD19 based on mRNA-LNP | Drug | WGb-0301 injection, Escalation doses, WGb-0301 injection, Extended doses |
Primary outcome
Dose limiting toxicity (DLT) and its incidence rate
Time frame: Within 90 days after the initial treatment
Maxmum tolerated dose (MTD) or optimal biological dose (OBD)
Time frame: Through study completion, an average of 2 years
2 secondary outcomes
Preliminary efficacy evaluation: The degree and rate of remission of biochemical indicators
Time frame: Through study completion, an average of 2 years
Preliminary efficacy evaluation: The degree and rate of remission of immunological indicators
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WGb-0301 injection in people with Autoimmune Diseases, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) and its incidence rate (time frame: Within 90 days after the initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.