Loading clinical trials...

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases

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

NCT06747156•Ruijin Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Ruijin Hospital

Shanghai, China

Key Dates

Start Date

December 23, 2024

Primary Completion Date

November 1, 2027

Completion Date

December 1, 2028

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Autoimmune Diseases

Interventions

ABO2203 Injection

DRUG

Contacts

Qiongyi Hu

CONTACT

18317071395 huqiongyi131@163.com

Deciphering the Genetic Architecture of Autoimmune Diseases

NCT06948110

Autoimmune Diseases

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

Deciphering the Genetic Architecture of Autoimmune Diseases

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

Clinical Study of AFN50 Injection in the Autoimmune Diseases

A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases

Natural History of Type 1 Interferonopathies: Insights From a European Cohort

CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases