Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048464
Status:
UNKNOWN
Last Update Posted:
2006-11-07
First Post:
2002-10-31
Brief Title:
T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
Sponsor:
Xcyte Therapies
Organization:
Xcyte Therapies
Study Overview
Official Title:
A Phase III Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will have immune cells collected and then expanded outside of the body Patients will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem cell transplantation Three days following the transplant patients will receive an infusion of a large number of expanded immune cells The goal of the study will be to determine the safety as well as potential efficacy of this treatment
Detailed Description:
This Phase III clinical study is designed to examine the safety of Xcellerated T Cells an activated autologous T cell product in study subjects undergoing an autologous peripheral blood stem cell transplant for the treatment of multiple myeloma Thirty-five patients will be treated Patients must have undergone induction therapy prior to study registration and may not have progressed following induction therapy or any other prior therapy for myeloma
Patients will undergo a steady state leukapheresis Xcellerate Leukapheresis to obtain peripheral blood mononuclear cells that will be used to produce Xcellerated T Cells During the Xcellerate Process T cells will be activated and expanded ex vivo by co-stimulation with anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic microbeads While the Xcellerated T Cells are being produced at Xcyte Therapies patients will be treated with a standard mobilization regimen consisting of cyclophosphamide and filgrastim Neupogen G-CSF followed by a second leukapheresis for collection of peripheral blood stem cells Patients will be treated with a standard high-dose chemotherapy regimen for multiple myeloma consisting of single agent melphalan 200mgm2 Patients will then receive their peripheral blood stem cells followed by post-transplant filgrastim for neutrophil recovery Three days Day 3 following stem cell infusion patients will receive a single dose Xcellerated T Cells
Patients will undergo a steady state leukapheresis Xcellerate Leukapheresis to obtain peripheral blood mononuclear cells that will be used to produce Xcellerated T Cells During the Xcellerate Process T cells will be activated and expanded ex vivo by co-stimulation with anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic microbeads While the Xcellerated T Cells are being produced at Xcyte Therapies patients will be treated with a standard mobilization regimen consisting of cyclophosphamide and filgrastim Neupogen G-CSF followed by a second leukapheresis for collection of peripheral blood stem cells Patients will be treated with a standard high-dose chemotherapy regimen for multiple myeloma consisting of single agent melphalan 200mgm2 Patients will then receive their peripheral blood stem cells followed by post-transplant filgrastim for neutrophil recovery Three days Day 3 following stem cell infusion patients will receive a single dose Xcellerated T Cells
Study Oversight
Has Oversight DMC:
None
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?:
None