NCT07349823

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DRUG	WGb-0301 injection	Drug targeting CD19 based on mRNA-LNP

Timeline

• Start date: 2026-01-26
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-01-20
• Last updated: 2026-01-20