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CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

Study acronym: CASTLE
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Lead sponsor: University of Erlangen-Nürnberg Medical School to Miltenyi Biomedicine GmbHv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06347718
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, Polymyositis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov