NCT07413341
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
Recruiting · Phase 1 · Therorna · registry updated 2026-10-19
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Understand trial procedures and methods, voluntarily sign the informed consent form .
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
- Bone marrow function: neutrophil count ≥ 1.5 × 10\^9/L, lymphocyte count ≥ 0.8 × 10\^9/L, hemoglobin ≥ 90 g/L, platelet ≥ 100 × 10\^9/L. Blood transfusion and growth factors must not be used within 14 days prior to screening to meet the above requirements.
- Coagulation function: international normalized ratio or activated partial thromboplastin time ≤ 1.5× upper limit of normal range (ULN).
- Cardiopulmonary function: left ventricular ejection fraction ≥ 50% on echocardiography; for lung function, dyspnea ≤Grade 1 of the NCI-CTCAE version 5.0 standards when breathing room air, and pulse oximetry ≥ 92%.
Exclusion
- Prohibited medications and treatments:
- Any RNA-LNP products or other LNP drugs received within the past two years.
- Received intravenous gamma immunoglobulin within 24 weeks prior to screening.