NCT06373081

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

A Clinical Study on the Safety and Efficacy of Anti-CD19-CD3E-CAR-T Cells in the Treatment of Relapsed or Refractory Autoimmune Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Sjogren's Syndrome
• Systemic Sclerosis
• Inflammatory Myopathy
• ANCA Associated Vasculitis
• Antiphospholipid Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD19-CD3E-CAR-T cells	The injection of anti-CD19-CD3E chimeric antigen receptor T (CAR-T) cells, referred to as anti-CD19-CD3E-CAR-T cells. The anti-CD19-CD3E-CAR protein is composed of a murine-derived CD19 single-chain variable fragment (scFv) FMC63, CD28 hinge and transmembrane regions, the intracellular domain of CD3E, the intracellular domain of CD28, and the intracellular domain of CD3ζ, all linked in sequence.

Timeline

• Start date: 2024-04-20
• Primary completion: 2025-04-15
• Completion: 2026-04-15
• First posted: 2024-04-18
• Last updated: 2024-04-18

Locations

1 site across 1 country: China