What is TI-0032-III injection studying for relapsed and refractory autoimmune diseases?

TI-0032-III injection is being studied as an in vivo CAR T cell therapy to target B cell-related autoimmune diseases that have relapsed or not responded to other treatments. Researchers aim to evaluate its safety and effectiveness in conditions like systemic lupus erythematosus, Sjögren's syndrome, and systemic sclerosis. The study is sponsored by Therorna and focuses on patients with difficult-to-treat autoimmune diseases.

Who may be eligible for this autoimmune diseases clinical trial?

Adults aged 18 to 65 with certain relapsed or refractory B cell-related autoimmune diseases may be eligible. They must have positive CD19 expression on blood B cells and meet specific disease activity and treatment history criteria. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this autoimmune diseases clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses for travel or other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

ID07413341

Phase 1 Study of TI-0032-III Injection CAR-T Cell Therapy for Adults with Relapsed or Resistant Autoimmune Diseases

Led by Therorna · Updated on 2026-02-17

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating an open-label, dose escalation study for patients with relapsed and refractory autoimmune diseases. The study focuses on a therapeutic biological product called TI-0032-III injection, which uses lipid nanoparticles to deliver circular RNA encoding the CD19 chimeric antigen receptor CAR targeting T cells. This treatment is intended for various difficult-to-treat B cell-related autoimmune diseases, including systemic lupus erythematosus, Sjgrens syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome. Participants will receive multiple doses of TI-0032-III injection infused into the body. This in vivo CD19-targeted CAR T cell therapy is being studied for safety and efficacy, with treatment delivered over a period involving dose escalation. The trial is an interventional Phase 1 study where the investigational injection is the main intervention. During the study, participants will be monitored for safety outcomes from the first dose up to 12 months. Researchers will also assess efficacy outcomes for the different autoimmune diseases up to 3 months after the first dose. Evaluations include clinical assessments and laboratory tests to measure treatment impact and safety. The total participant involvement will span at least one year to observe safety and disease response.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Understand trial procedures and voluntarily sign the informed consent form
Age between 18 and 65 years, any gender
Positive CD19 expression on peripheral blood B cells by flow cytometry
Bone marrow function with neutrophil count ≥ 1.5 × 10^9/L, lymphocyte count ≥ 0.8 × 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 10^9/L without recent transfusion or growth factors
Coagulation function with INR or aPTT ≤ 1.5 times upper limit of normal
Cardiopulmonary function with left ventricular ejection fraction ≥ 50%, dyspnea grade ≤ 1 on room air, pulse oximetry ≥ 92%
Liver function with ALT, AST, total bilirubin ≤ 1.5 times upper limit of normal
Renal function with creatinine clearance ≥ 50 mL/min
Meet specific disease criteria for systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis including disease activity and treatment history as detailed in the protocol

You will not qualify if you...

Received any RNA-LNP or other lipid nanoparticle drugs in the past 2 years
Received intravenous gamma immunoglobulin within 24 weeks prior to screening
Received plasmapheresis therapy within 12 weeks prior to screening
Not fully recovered from surgery within 4 weeks prior to screening
Epilepsy or use of psychotropic or sedative drugs during screening (except sleeping medications)
Received any live or live attenuated vaccine within 12 weeks prior to screening or plan vaccination during trial
Participated in other drug or device clinical trials within 12 weeks prior to screening (except screening failures)
History of severe lupus nephropathy requiring hemodialysis or high-dose corticosteroids recently
Active central nervous system lupus or related neurological conditions
Other systemic inflammatory diseases within 12 weeks prior to screening (except secondary Sjögren's syndrome)
Severe heart conditions or poorly controlled hypertension
Active or uncontrolled infections including HIV, hepatitis B or C
Known allergy or severe hypersensitivity to TI-0032-III or similar drugs
Thyroid disorders or suspicious thyroid nodules
History of splenectomy or recent major surgery
Serious mental illness or recent substance abuse
History of major organ or bone marrow transplantation
History of malignancy or serious liver disease
Women pregnant, breastfeeding, planning pregnancy, or not using contraception
Other significant abnormal lab or imaging findings deemed unsuitable for trial participation

Research Team

Xiao bing Wang, PhD

Hu ji Xu, PhD

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Phase 1 Study of TI-0032-III Injection CAR-T Cell Therapy for Adults with Relapsed or Resistant Autoimmune Diseases

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria