NCT06747156 A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
| NCT ID | NCT06747156 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Ruijin Hospital |
| Condition | Autoimmune Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-12-23 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria
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.
Contact & Investigator
Chengde Yang
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06747156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06747156 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06747156 currently recruiting?
Yes, NCT06747156 is actively recruiting participants. Contact the research team at huqiongyi131@163.com for enrollment information.
Where is the NCT06747156 trial being conducted?
This trial is being conducted at Wuhan, China, Nanjing, China, Shanghai, China.
Who is sponsoring the NCT06747156 clinical trial?
NCT06747156 is sponsored by Ruijin Hospital. The principal investigator is Chengde Yang at Ruijin Hospital. The trial plans to enroll 66 participants.