NCT06420154

The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases

An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed/Refractory Autoimmune Diseases

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · 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-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-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 the last participant finishes 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-CAR-T cells	The subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy. Dosage：1×10\^5 cells/Kg; 3×10\^5 cells/Kg; 1×10\^6 cells/Kg frequency：single infusion

Timeline

• Start date: 2024-05-27
• Primary completion: 2027-05-27
• Completion: 2027-05-27
• First posted: 2024-05-17
• Last updated: 2024-05-17

Locations

1 site across 1 country: China