Exploratory Study on the Treatment of Relapsed and Refractory Immune Related Diseases With WGb-0301 Injection

January 15, 2026 updated by: Jiyan Liu, West China Hospital

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

47

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WGb-0301 injection, Escalation doses
Drug: WGb-0301 injection
Drug targeting CD19 based on mRNA-LNP
Experimental: WGb-0301 injection, Extended doses
Drug: WGb-0301 injection
Drug targeting CD19 based on mRNA-LNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose limiting toxicity (DLT) and its incidence rate
Time Frame: Within 90 days after the initial treatment
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
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Preliminary efficacy evaluation: The degree and rate of remission of biochemical indicators
Time Frame: Through study completion, an average of 2 years
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
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 26, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0301-IIT-ADs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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