NCT06347718

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.

Conditions

• Systemic Lupus Erythematosus
• Systemic Sclerosis
• Dermatomyositis
• Polymyositis

Interventions

Type	Name	Description
DRUG	anti-CD19 CAR T cell therapy	Single-dose

Timeline

• Start date: 2023-07-17
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-04-04
• Last updated: 2025-09-30

Locations

1 site across 1 country: Germany