---
title: A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
nct_id: NCT06747156
overall_status: RECRUITING
phase: EARLY_PHASE1
sponsor: Ruijin Hospital
study_type: INTERVENTIONAL
primary_condition: Autoimmune Diseases
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06747156.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06747156"
ct_last_update_post_date: 2026-03-24
last_seen_at: "2026-05-12T07:08:52.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases

**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

**NCT ID:** [NCT06747156](https://clinicaltrials.gov/study/NCT06747156)

## Key Facts

- **Status:** RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** Ruijin Hospital
- **Collaborators:** Abogen Life Sciences (Shanghai) Co., Ltd.
- **Conditions:** Autoimmune Diseases
- **Start Date:** 2024-12-23
- **Completion Date:** 2028-12
- **CT.gov Last Update:** 2026-03-24

## Brief 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). The trial included dose escalation and dose expansion parts.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. ≥18 years of age at time of informed consent.
2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.
3. Inadequate response to SoCs or relapsed after the treatment.
4. Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.
5. Sufficient organ function.

Exclusion Criteria:

1. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.
2. Severe hypogammaglobulinemia or IgA deficiency.
3. Active hepatitis or with a history of severe liver disease.
4. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.
5. Severe cardiovascular diseases.
6. History of cancer within past 5 years.
7. Have other serious medical conditions.
8. Received any of B cell targeted therapies and biologic therapies within the defined time window.
9. History of severe allergies or known allergies to any active or inactive component of the study drug(s).
10. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
```

## Arms

- **ABO2203** (EXPERIMENTAL)

## Interventions

- **ABO2203 Injection** (DRUG) — Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager

## Primary Outcomes

- **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.)_

## Locations (3)

- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China — _NOT_YET_RECRUITING_
- Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China — _RECRUITING_
- Ruijin Hospital, Shanghai, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.union hospital, tongji medical college, huazhong university of science and technology|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.nanjing drum tower hospital|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.ruijin hospital|shanghai||china` — added _(2026-05-12)_

---

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