Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT06347718
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Study Overview
Official Title:
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASTLE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: