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NCT Number: NCT06747156

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age at time of informed consent.
  • Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
  • Inadequate response to SoCs or relapsed after the treatment.
  • Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.
  • Sufficient organ function.

Exclusion criteria

  • Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.
  • Severe hypogammaglobulinemia or IgA deficiency.
  • Active hepatitis or with a history of severe liver disease.
  • History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.
  • Severe cardiovascular diseases.
  • History of cancer within past 5 years.
  • Have other serious medical conditions.
  • Received any of B cell targeted therapies and biologic therapies within the defined time window.
  • History of severe allergies or known allergies to any active or inactive component of the study drug(s).
  • A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.

Treatment and study plan

ABO2203 Injection

Drug

Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager

Primary outcomes

  1. The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.

    Time frame: from the first dose of study treatment to 30 days after the last dose of study treatment.

  2. The incidence, severity, and nature of serious TEAEs (TESAE)s .

    Time frame: from the first dose of study treatment to 30 days after the last dose of study treatment.

  3. The incidence, severity, and nature of TEAEs leading to interruption or early termination of study treatment.

    Time frame: from the first dose of study treatment to 30 days after the last dose of study treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiongyi Hu

CONTACT

[email protected]

18317071395

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Abogen Life Sciences (Shanghai) Co., Ltd.

Registry information

Official study title

A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 24, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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