Actively Recruiting
A Study 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
205 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
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.
CONDITIONS
Official 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
- Diagnosed with autoimmune diseases according to disease classification criteria
- Had inadequate response to standard of care treatments or relapsed after treatment
- On a stable dose of standard of care treatments for at least 4 weeks prior to enrollment
- Have 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, uncontrolled eczema or asthma
- Severe cardiovascular diseases
- History of cancer within the past 5 years
- Other serious medical conditions
- Received B cell targeted or biologic therapies within the defined time window
- History of severe allergies or known allergies to any component of the study drug
- 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
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
CONTACT
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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