A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
- 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
- ≥18 years of age at time of informed consent.
- Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
- Inadequate response to SoCs (at least 2 of first-line treatment drugs, including glucocorticoids and immunosuppressants, etc.) or relapsed after the treatment.
- The results of clinical laboratory tests achieved during the screening period meet relevant criteria defined in the study protocol.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABO2203 ABO2203 Injection -
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does ABO2203's CD19/CD3 T cell engager mechanism modulate B cell and T cell interactions in autoimmune diseases?
What comparative efficacy and safety data exist for ABO2203 versus rituximab in refractory autoimmune diseases?
Which biomarkers predict response to ABO2203 mRNA therapy in CD19+ autoimmune disease patients?
What are the potential immune-related adverse events and management strategies for ABO2203 in clinical trials?
How does ABO2203's mRNA-based T cell engager compare to other bispecific antibodies in autoimmune disease treatment?
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, China
Ruijin Hospital🇨🇳Shanghai, ChinaChengde YangPrincipal Investigator