Trials / Recruiting
RecruitingNCT07413341
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
A Clinical Study on the Safety and Efficacy of in Vivo CAR-T Cell Therapy (TI-0032-III Injection) for the Treatment of Relapsed and Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Therorna · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TI-0032-III injection | Multiple doses of TI-0032-III injection will be infused |
Timeline
- Start date
- 2026-01-22
- Primary completion
- 2026-05-01
- Completion
- 2027-01-30
- First posted
- 2026-02-17
- Last updated
- 2026-02-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07413341. Inclusion in this directory is not an endorsement.