A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABO2203 Injection.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug ABO2203 Injection
Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager
Primary outcome measures
- 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.]
- 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.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Nanjing Drum Tower Hospital — Nanjing
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT06747156 · ABO2203-001