Clinical Trial

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

Study acronym: CASTLE
Recruiting Phase 1/2
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Record status
This record was last updated September 30, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-03.
Trial Details
NCT Number NCT06347718
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, Polymyositis
Enrollment 24 participants
Start Date 2023-07-17
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-30