Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease

Status Recruiting

Clinical Trial Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases.

Clinical Trial Description

This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases. Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit of 12 weeks after CAR-T cells infusion. ;

Study Design

Related Conditions & MeSH terms

ANCA Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Antiphospholipid Syndrome
Autoimmune Diseases
Inflammatory Myopathy
Lupus Erythematosus, Systemic
Myositis
Scleroderma, Systemic
Sjogren's Syndrome
Syndrome
Systemic Lupus Erythematosus (SLE)
Systemic Sclerosis
Vasculitis

Clinical Trial Details

NCT number	NCT06373081
Study type	Interventional
Source	Shanghai Changzheng Hospital
Contact	Huji Xu, Ph.D, MD
Phone	86021-81885514
Email	xuhuji@smmu.edu.cn
Status	Recruiting
Phase	N/A
Start date	April 20, 2024
Completion date	April 15, 2026

View Details

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