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

RECRUITINGPHASE1

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

NCT07413341•Therorna

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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%.
•Liver function: alanine aminotransferase ≤ 1.5 × ULN, aspartate aminotransferase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN (total bilirubin at least ≤ 3.0 mg/dL in patients with Gilbert syndrome).
•Renal function: creatinine clearance (by Cockcroft-Gault formula) ≥ 50 mL/min.
•Criteria for SLE：
•1. Meet the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
+27 more criteria

Exclusion Criteria

•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.
•* Received plasmapheresis therapy within 12 weeks prior to screening.
•* Subjects who have not fully recovered from surgery within 4 weeks prior to screening.
•* Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).
•* Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.
•* Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for those whose screening failed).
•Concomitant diseases or clinical condition:
•* History of lupus nephropathy requiring hemodialysis or treatment with high-dose corticosteroids (\> 100 mg/d prednisone or equivalent) within 90 days prior to baseline.
+16 more criteria

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 22, 2026

Primary Completion Date

May 1, 2026

Completion Date

January 30, 2027

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus (SLE)Sjogren's Syndrome (SS)Systemic Sclerosis (SSc)Inflammatory MyopathyANCA Associated Systemic Vasculitis

Interventions

TI-0032-III injection

BIOLOGICAL

Contacts

Xiao bing Wang, PhD

CONTACT

021-81886999 gale820907@163.com

Hu ji Xu, PhD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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