Actively Recruiting
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
Led by Ruijin Hospital · Updated on 2026-03-24
66
Participants Needed
3
Research Sites
56 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
A
Abogen Life Sciences (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an mRNA drug called ABO2203, which encodes a CD19/CD3 T cell engager, in patients with autoimmune diseases that have not responded well or have relapsed after standard treatments. This early phase 1 study focuses on patients with refractory autoimmune diseases who have shown inadequate response to standard care or have relapsed. The study involves administering ABO2203 injection as the investigational treatment. It includes a dose escalation phase to determine appropriate dosing and a dose expansion phase to further assess safety and preliminary efficacy. Participants will receive the study drug under medical supervision, with close monitoring throughout the treatment period. Participants will be observed from the first dose of the study treatment up to 30 days after the last dose for any treatment-emergent adverse events, including serious events and those causing interruption or early termination of treatment. The research team will carefully monitor these safety outcomes while also assessing how the drug behaves in the body. The study is expected to continue until December 2028, and participants will be involved during the treatment and follow-up periods as scheduled by the research team.
CONDITIONS
Brief Title
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Diagnosis of autoimmune diseases according to disease classification criteria
- Inadequate response to standard of care treatments or relapse after treatment
- Stable dose of standard of care treatments for at least 4 weeks prior to enrollment
- Sufficient organ function
You will not qualify if you...
- Active infection, including tuberculosis or active/relapsed peptic ulcer
- Severe hypogammaglobulinemia or IgA deficiency
- Active hepatitis or history of severe liver disease
- History of rapid allergic reactions, eczema, or asthma not controlled by topical corticosteroids
- Severe cardiovascular diseases
- History of cancer within the past 5 years
- Other serious medical conditions
- Recent use of B cell targeted or biologic therapies within defined time window
- History of severe allergies or known allergies to any study drug components
- History of organ, bone marrow, or hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From first dose until 30 days after the last dose
Participants receive ABO2203 injections, an mRNA drug targeting CD19/CD3 T cells, to treat refractory autoimmune diseases.
Trial Site Locations
Total: 3 locations
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
3
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qiongyi Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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