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

NCT07413341 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Sjogren's Syndrome (SS)
  • Systemic Sclerosis (SSc)
  • Inflammatory Myopathy
  • ANCA Associated Systemic Vasculitis

Interventions

BIOLOGICAL

TI-0032-III injection

Multiple doses of TI-0032-III injection will be infused

Sponsors & Collaborators

  • Therorna

    lead INDUSTRY

Principal Investigators

  • Hu ji Xu · Shanghai Changzheng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2026-05-01
Completion
2027-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413341 on ClinicalTrials.gov