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

Early Phase 1

Not yet recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: ABO2203 Injection

• Registration Number: NCT06747156
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-11
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 1. ≥18 years of age at time of informed consent. 2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria, including but not limited to systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (SSc), and idiopathic inflammatory myopathy (IIM).

  2. Diagnosis of SLE defined as fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria of SLE.

  3. Diagnosis of lupus nephritis (LN): active, biopsy-proven LN Class III or IV ± V by 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.

     Active SLE disease, as demonstrated by a SLE disease activity index (SLEDAI-2K) total score of ≥6 with a clinical score of ≥4.

  4. Diagnosis of RA: meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.

     Moderate or severe active RA disease, as demonstrated by minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count, ESR≥28mm/h, and CRP>7.0mg/L at the screening visit.

     3. Inadequate response to SoCs (at least 2 of first-line treatment drugs, including glucocorticoids and immunosuppressants, etc.) or relapsed after the treatment.

     4. The results of clinical laboratory tests achieved during the screening period meet relevant criteria defined in the study protocol.

     5. Received relevant background SoCs at least 12 weeks prior to screening, and with a stable dose at least 4 weeks prior to the enrollment, it must be planned that the background SoC treatment remains at the stable dose throughout the study period.

     6. Sufficient organ function.

Exclusion Criteria

• 1. Criteria for relevant autoimmune diseases, e.g., SLE: Active severe or unstable lupus-associated neuropsychiatric SLE. LN: Active central nervous system (CNS) lupus RA: experienced surgery in joint or intraarticular glucocorticoid therapy within 8 weeks prior to screening; experienced inflammatory joint disease other than RA.

  2. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.

  3. Severe hypogammaglobulinemia or IgA deficiency. 4. Active hepatitis or with a history of severe liver disease. 5. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.

  4. Severe cardiovascular diseases. 7. History of cancer within past 5 years. 8. Have other serious medical conditions. 9. Received any of B cell targeted therapies within 48 weeks prior to screening.

  5. Received TNF-α antagonists, IL-6 antagonists, IL-1 antagonists, selective T cell co-stimulatory factor inhibitors, etc. within 48 weeks prior to screening.

  6. Received non biologic therapy within 4 weeks prior to screening or 5 known drug half-lives (whichever is shorter).

  7. History of severe allergies or known allergies to any active or inactive component of the study drug(s).

  8. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABO2203	ABO2203 Injection	-

Primary Outcome Measures

Name	Time	Method
The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.	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 .	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.	from the first dose of study treatment to 30 days after the last dose of study treatment.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China