RecruitingPhase 1NCT07413341

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


Sponsor

Therorna

Enrollment

12 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests TI-0032-III, a new type of cell-based injection therapy (using engineered immune cells that target a protein called CD19) in adults with relapsed or refractory autoimmune diseases — specifically lupus (SLE), Sjögren's syndrome, systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis — that have not responded to standard treatments. **You may be eligible if...** - You are 18 to 65 years old - You have one of the qualifying autoimmune diseases (lupus, Sjögren's, systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis) - Your disease is moderate to severely active despite prior treatment with standard medications including steroids, immunosuppressants, and biologic drugs - Your CD19 protein levels on B cells are positive by lab testing - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You received an RNA-lipid nanoparticle product within the past 2 years - You have received intravenous immunoglobulin (IVIG) within the past 24 weeks - You have active epilepsy or use certain sedative/psychotropic medications - You have active or poorly controlled infections, including HIV or hepatitis - You have a history of cancer - You are pregnant, breastfeeding, or unable to use effective contraception for 12 months after the last dose Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTI-0032-III injection

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


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT07413341


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