Actively Recruiting
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
Led by Therorna · Updated on 2026-02-17
12
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
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, Sjögren's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until 3 months
Participants receive multiple doses of TI-0032-III injection for in vivo CAR-T cell therapy to treat relapsed and refractory autoimmune diseases.
Multiple infusion visits during treatment period
Duration - Up to 12 months after first dose
Participants are monitored for safety outcomes up to 12 months after the first dose of TI-0032-III injection.
Regular visits for safety monitoring during follow-up
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
X
Xiao bing Wang, PhD
H
Hu ji Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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