Clinical Trial

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

Study acronym: in vivo CAR-T
Recruiting Phase 1
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Record status
This record was last updated February 17, 2026 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.
Trial Details
NCT Number NCT07413341
Lead Sponsor Therorna
Conditions Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy, ANCA Associated Systemic Vasculitis
Enrollment 12 participants
Start Date 2026-01-22
Primary Completion 2026-05-01 (estimated)
Study Completion 2027-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-17