mRNA (ABO2203) that delivers a CD19/CD3 T‑cell engager for people with refractory autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early phase 1 program gives escalating doses of ABO2203, an mRNA formulation that encodes a CD19/CD3 T‑cell engager, by injection to adults with autoimmune diseases who had inadequate response or relapse after standard therapies. The design includes a dose‑escalation portion to find a tolerable dose and a dose‑expansion portion to gather additional safety and early activity data. Key outcomes collected include safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy signals. Participants must meet disease‑specific diagnostic criteria, be on a stable background therapy, and have adequate organ function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Ruijin Hospital
  Shanghai, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Principal investigator: Chengde Yang — Ruijin Hospital
• Study coordinator: Qiongyi Hu
• Email: huqiongyi131@163.com
• Phone: 18317071395

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.