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A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases | Clinical Trials | Clareo Health

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A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases

A Study to Evaluate the Safety and Efficacy of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases

NCT07212322•Institute of Hematology & Blood Diseases Hospital, China

Summary

The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.

Detailed Description

This is a single-center, one-arm, open-label study aiming to evaluate the safety and efficacy of CD19 UCAR-T Cellsin subjects with autoimmune diseases. The study process is divided into five periods, including screening, lymphodepletion, treatment, DLT observation and follow-up.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, between 18 and 65 years old;
•Adequate organ functions, defined as follows:
•Hematological function \[no transfusion and no use of granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to testing\]: white blood cells (WBC) ≥3.0×10\^9/L, absolute neutrophil count (ANC)≥1.0×10\^9/L, platelet count (PLT)≥50×10\^9/L (ITP subjects are without restrictions), hemoglobin ≥80 g/L.
•Coagulation function: international normalized ratio (INR) ≤ 1.5×upper limit of normal value （ULN）, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
•Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×(ULN), and total bilirubin ≤1.5×ULN. 4)Renal function: serum creatinine ≤1.5×ULN or creatinine clearance (calculated by Cockcroft Gault formula) ≥ 40 ml/min.
•Cardiac function: New York Heart Association (NYHA) Grade I or II, and left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO), with no pericardial effusion, and no clinically significant abnormalities on12-lead electrocardiogram (ECG).
•Pulmonary function: oxygen saturation ≥92% on room air (without supplemental oxygen), no clinically significant pleural effusion.
•Subjects with fertile partners must agree to use effective contraception throughout the treatment period and for 24 months after treatment, and must refrain from donating eggs/sperm for assisted reproduction during this period; Female subjects of childbearing potential (excluding those who have undergone sterilization or ≥12 months of menopause) must have negative urine or blood pregnancy test results during screening.
•Voluntary participates this trial and can comprehend and sign ICF.
•For subjects with moderate to severe refractory Systemic Lupus Erythematosus:
+23 more criteria

Exclusion Criteria

•Patients with a history or concurrent diagnosis of active malignancies, including tumor-associated polymyositis/dermatomyositis, are excluded. Exceptions include cured or non-recurrent cervical carcinoma in situ for at least 3 years, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, or ductal carcinoma in situ after radical surgery.
•Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products.
•Patients with severe pulmonary diseases within the past year, such as moderate to severe pulmonary hypertension (pulmonary artery systolic pressure \> 50 mmHg on echocardiography), or those requiring oxygen therapy via a reservoir mask or non-invasive/invasive mechanical ventilation during screening.
•Patients who have received any of the following medications or treatments within the specified timeframes:
•B-cell-depleting therapy within 6 months before screening, assessed by the investigator as not having failed treatment, including anti-CD20, anti-CD22, anti-CD52, anti-CD38 or ant-BCMA monoclonal antibodies or bispecific antibodies.
•High-dose intravenous immunoglobulin (IVIG) within 3 months before screening. Dialysis or plasmapheresis within 2 months before screening. Glucocorticoid pulse therapy (defined as ≥ 200 mg/day prednisone or equivalent doses of other glucocorticoids) within 2 months before screening.
•Used telitacicept within 6 weeks before screening, or belimumab within 8 weeks before screening.
•Thrombopoietin (TPO) or TPO receptor agonists (TPO-RA) or any other medication with a clearly indicated platelet-boosting effect, ortransfusion therapy (including platelet transfusion) within 2 weeks before screening (ITP subjects are without restrictions).
•Patients with a history of severe central nervous system (CNS) disorders history or related symptoms (excluding isolated trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular diseases, encephalitis, brain injury, aneurysm, cerebellar disorders, organic brain syndrome, Parkinson's disease as well as symptoms such as epilepsy, convulsion, aphasia, dementia.
•Complicated with severe renal disease, defined as any of the following within 8 weeks before screening:
+23 more criteria

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

January 30, 2026

Primary Completion Date

May 20, 2027

Completion Date

July 20, 2027

Last Updated

December 19, 2025

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus ErythematosusIdiopahic Inflammatory MyopathiesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSjögren's SyndromeAntiphospholipid SyndromeImmune ThrombocytopeniaSystemic Sclerosis

Interventions

CD19 UCAR-T cells

DRUG

Contacts

Ying Wang, Dr.

CONTACT

+86-22-23909278 wangying1@ihcams.ac.cn

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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: December 19, 2025Data 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 Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

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