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

Sponsor
West China Hospital
Study ID
NCT07349823
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • WGb-0301 injection — DRUG
    Drug targeting CD19 based on mRNA-LNP

Study Details

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).

Key Dates

First listed
Jan 20, 2026
Start date
Jan 26, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
47 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: WGb-0301 injection, Escalation doses
  • Experimental: WGb-0301 injection, Extended doses

Primary Outcome Measure

Dose limiting toxicity (DLT) and its incidence rate [ Time Frame: Within 90 days after the initial treatment ]

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