Autoimmune DiseasesEarly Phase 1NCT06747156
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
A Early Phase 1 study testing ABO2203 Injection in people with Autoimmune Diseases, run by Ruijin Hospital at 3 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- ABO2203 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesChina
- Study dates
- 23 Dec 2024to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Yulin Geng, MD
Lingyun Sun, MD
- Recruiting
Ruijin Hospital
Shanghai
Chengde Yang
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Chunli Mei, MD
Anbin Huang
About this study
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
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
- Autoimmune Diseases
- Being tested
- ABO2203 Injection
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO2203 InjectionDrug
Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager
| Study group | Role | What they receive |
|---|---|---|
| ABO2203 | Experimental | Not described Receives: Drug: ABO2203 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.
Measured: 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 .
Measured: 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.
Measured: from the first dose of study treatment to 30 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start23 Dec 2024
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abogen Life Sciences (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chengde Yang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747156
- Sponsor's protocol ID
- ABO2203-001
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06747156
- Acronym / sponsor ID
- ABO2203-001
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Abogen Life Sciences (Shanghai) Co., Ltd.
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABO2203 | Experimental | Drug: ABO2203 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABO2203 InjectionName of Active Ingredient: mRNA encoding CD19/CD3 T cell engager | Drug | ABO2203 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengde Yang principal investigator
Ruijin Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ABO2203 Injection in people with Autoimmune Diseases, run by Ruijin Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiongyi Hu (18317071395, huqiongyi131@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.