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

NCT06747156 | Recruiting Early Phase 1

• 1 other identifier: ABO2203-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

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

Study Arms (1)

ABO2203

EXPERIMENTAL

Drug: ABO2203 Injection

Interventions

ABO2203 Injection DRUG

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

ABO2203

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Abogen Life Sciences (Shanghai) Co., Ltd.: collaborator

Study Sites (3)

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

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Chengde Yang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiongyi Hu

CONTACT

18317071395; huqiongyi131@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 24, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-02

Locations

CN (3)