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.
≥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.
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.
Single group
ABO2203 Injection
DrugName of Active Ingredient: mRNA encoding CD19/CD3 T cell engager
The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.
The incidence, severity, and nature of serious TEAEs (TESAE)s .
The incidence, severity, and nature of TEAEs leading to interruption or early termination of study treatment.
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Ruijin Hospital
Lead sponsor
Abogen Life Sciences (Shanghai) Co., Ltd.
Collaborator
