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

NCT07212322 | Not Yet Recruiting

• 1 other identifier: IIT2025102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus; Idiopahic Inflammatory Myopathies; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Sjögren's Syndrome; Antiphospholipid Syndrome; Immune Thrombocytopenia; Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity

  Time Frame: 0~28 day after treatment

• Frequency of AEs, SAEs

  Time Frame: from lymphodepletion to 12 months after treatment

Study Arms (1)

treatment

EXPERIMENTAL

Drug: CD19 UCAR-T cells

Interventions

CD19 UCAR-T cells DRUG

CD19 UCAR-T cells treatment

treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE.
• Positive for antinuclear antibody (ANA) (titer ≥1:80) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening.
• SLEDAI-2000 score ≥8 at screening; if points are attributed for low complement and/or anti-dsDNA antibody, the SLEDAI-2000 clinical symptom score (excluding points for low complement and/or anti-dsDNA antibody) must be ≥6.
• A history of at least 6 months of stable standard treatment regimen prior to screening, with failure to achieve LLDAS criteria for at least 2 months before screening. Standard treatment regimen refers to stable use of any of the following medications (alone or in combination):
• glucocorticoids, antimalarials, biologics, and other immunosuppressants or immunomodulators.

You may not qualify if:

• 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:
• Severe lupus nephritis \[defined as urine protein \> 6g/24h or serum creatinine \> 1.5×ULN.
• Creatinine clearance (Cockcroft Gault formula) \< 40mL/min\]. Active nephritis requiring treatment that are prohibited per protocol. Requiring hemodialysis or plasmapheresis, or receiving prednisone \> 100mg/d or equivalent corticosteroid therapy ≥14 days.
• Patients with severe allergies to any components of the lymphodepletion regimen or CD19 UCAR-T therapy used in this study.
• Patients who meet any of the following criteria:
• Positive for hepatitis B surface antigen (HBsAg) AND positive for hepatitis B core antibody (HBcAb) with detectable HBV DNA in peripheral blood.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Sjogren's Syndrome; Antiphospholipid Syndrome; Purpura, Thrombocytopenic, Idiopathic; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Ying Wang, Dr.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)