A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
NCT ID: NCT06747156
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
66 participants
INTERVENTIONAL
2024-12-23
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABO2203
ABO2203 Injection
Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager
Interventions
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ABO2203 Injection
Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
3. Inadequate response to SoCs or relapsed after the treatment.
4. Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.
5. Sufficient organ function.
Exclusion Criteria
2. Severe hypogammaglobulinemia or IgA deficiency.
3. Active hepatitis or with a history of severe liver disease.
4. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.
5. Severe cardiovascular diseases.
6. History of cancer within past 5 years.
7. Have other serious medical conditions.
8. Received any of B cell targeted therapies and biologic therapies within the defined time window.
9. History of severe allergies or known allergies to any active or inactive component of the study drug(s).
10. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
18 Years
ALL
No
Sponsors
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Abogen Life Sciences (Shanghai) Co., Ltd.
UNKNOWN
Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Chengde Yang
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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ABO2203-001
Identifier Type: -
Identifier Source: org_study_id
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