Actively Recruiting
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
Led by Therorna · Updated on 2026-02-17
12
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Ages 18 to 65 years, any gender
- Positive CD19 expression on peripheral blood B cells confirmed by flow cytometry
- Adequate bone marrow function: neutrophil count ≥ 1.5 × 10^9/L, lymphocyte count ≥ 0.8 × 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 10^9/L
- Coagulation function: INR or aPTT ≤ 1.5 times upper limit of normal
- Cardiopulmonary function: ejection fraction ≥ 50%, dyspnea grade ≤ 1 on room air, pulse oximetry ≥ 92%
- Liver function: ALT and AST ≤ 1.5 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit (or ≤ 3.0 mg/dL with Gilbert syndrome)
- Renal function: creatinine clearance ≥ 50 mL/min
- Specific disease criteria met for systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis, including disease activity scores and prior treatment history
You will not qualify if you...
- Use of RNA-LNP products or other LNP drugs within past two years
- Received intravenous gamma immunoglobulin within 24 weeks before screening
- Received plasmapheresis within 12 weeks before screening
- Not fully recovered from surgery within 4 weeks before screening
- Epilepsy or use of psychotropic/sedative drugs during screening (except sleeping aids)
- Received live or live attenuated vaccine within 12 weeks before screening or requiring vaccination during trial
- Participation in other drug or device clinical trials within 12 weeks before screening (except screening failures)
- History of lupus nephropathy requiring hemodialysis or high-dose corticosteroids within 90 days before baseline
- Active central nervous system lupus or certain neurological conditions
- Other systemic inflammatory diseases within 12 weeks before screening (except secondary Sjogren's syndrome)
- Severe heart failure, unstable angina, recent heart attack, or poorly controlled hypertension
- Active or uncontrolled infections, including HIV, hepatitis B or C
- Known allergy to TI-0032-III or similar drugs
- History of thyrotoxicosis or suspicious thyroid nodules
- Previous splenectomy or loss of spleen function, recent major surgery, or planned surgery during trial
- Serious mental illness or recent substance abuse
- History of major organ or stem cell transplant
- History of malignancy or serious liver disease
- Positive pregnancy test or inability to use effective contraception during and 12 months after treatment
- Other clinically significant abnormal laboratory or imaging tests deemed unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
X
Xiao bing Wang, PhD
CONTACT
H
Hu ji Xu, PhD
CONTACT
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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