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

Early Phase 1
Recruiting
Conditions
Autoimmune Diseases
Interventions
Registration Number
NCT06747156
Lead Sponsor
Ruijin Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
26
Inclusion Criteria
  1. ≥18 years of age at time of informed consent.
  2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
  3. Inadequate response to SoCs (at least 2 of first-line treatment drugs, including glucocorticoids and immunosuppressants, etc.) or relapsed after the treatment.
  4. The results of clinical laboratory tests achieved during the screening period meet relevant criteria defined in the study protocol.
  5. Received relevant background SoCs at least 12 weeks prior to screening, and with a stable dose at least 4 weeks prior to the enrollment, it must be planned that the background SoC treatment remains at the stable dose throughout the study period.
  6. Sufficient organ function.
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 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ABO2203ABO2203 Injection-
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ruijin Hospital

🇨🇳

Shanghai, China

Ruijin Hospital
🇨🇳Shanghai, China
Chengde Yang
Principal Investigator

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