Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT02135406
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2014-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CART-19 for Multiple Myeloma
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-CD19 Attached To TCRζ And 4-1BB Signaling Domains Coupled With Salvage Autologous Stem-Cell Transplantation (ASCT) In Multiple Myeloma Patients With Early Relapse/Progression After Initial ASCT
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T cells on day +2 after autologous stem cell infusion following high-dose melphalan.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: