A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases

Last updated: March 22, 2026
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

ABO2203 Injection

Clinical Study ID

NCT06747156
ABO2203-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with refractory autoimmune diseases who received inadequate response or relapsed from standard of care (SoC). The trial included dose escalation and dose expansion parts.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years of age at time of informed consent.

  2. Diagnosis of autoimmune diseases according to the corresponding diseaseclassification 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

Exclusion Criteria:

  1. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.

  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 bytopical 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 definedtime window.

  9. History of severe allergies or known allergies to any active or inactive componentof the study drug(s).

  10. A history of organ transplantation, bone marrow transplantation or hematopoieticstem cell transplantation.

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: ABO2203 Injection
Phase: 1
Study Start date:
December 23, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Ruijin Hospital

    Shanghai,
    China

    Active - Recruiting

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