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

Sponsor
Ruijin Hospital
Study ID
NCT06747156
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABO2203 Injection — DRUG
    Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager

Study Details

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.

Key Dates

First listed
Dec 24, 2024
Start date
Dec 23, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABO2203

Primary Outcome Measure

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. ]

Central Contacts

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