Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01621724
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2012-03-22
Brief Title:
WT1 TCR Gene Therapy for Leukaemia A Phase III Safety and Toxicity Study
Sponsor:
Cell Medica Ltd
Organization:
Cell Medica Ltd
Study Overview
Official Title:
WT1 TCR Gene Therapy for Leukaemia A Phase III Safety and Toxicity Study
Status:
COMPLETED
Status Verified Date:
2018-10
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:
WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid leukaemia
Patients white blood cells T cells are modified to specifically fight the leukaemia cells by transferring a gene into the T cells which allows them to recognize fragments of a protein called WT1 This protein is present on the surface of leukaemia cells at very high levels The gene transferred to the T cells enables them to make a new T cell receptor TCR which will allow them to attack leukaemia cells with high levels of WT1 on their surface
Using this form of gene therapy the investigators can convert some of the patients immune systems own T cells into T cells that the investigators hope will be much more effective at recognizing and killing leukaemia cells
Patients white blood cells T cells are modified to specifically fight the leukaemia cells by transferring a gene into the T cells which allows them to recognize fragments of a protein called WT1 This protein is present on the surface of leukaemia cells at very high levels The gene transferred to the T cells enables them to make a new T cell receptor TCR which will allow them to attack leukaemia cells with high levels of WT1 on their surface
Using this form of gene therapy the investigators can convert some of the patients immune systems own T cells into T cells that the investigators hope will be much more effective at recognizing and killing leukaemia cells
Detailed Description:
This trial concerns a novel approach to generating leukaemia antigen-specific T cells for adoptive cellular therapy in HLA-A0201 patients with acute myeloid leukaemia AML and chronic myeloid leukaemia CML
In this study patient T cells will be gene-modified using a GMP grade retroviral vector containing the genes for a WT1-specific HLA-A2-restricted T cell receptor This ex vivo gene therapy will generate T cells expressing the WT1-specific TCR and thus able to recognise WT1-expressing target cells
The autologous Cys1 WT1 TCR-transduced T cells will be re-infused back into adult leukaemia patients following lymphodepleting conditioning
In this study patient T cells will be gene-modified using a GMP grade retroviral vector containing the genes for a WT1-specific HLA-A2-restricted T cell receptor This ex vivo gene therapy will generate T cells expressing the WT1-specific TCR and thus able to recognise WT1-expressing target cells
The autologous Cys1 WT1 TCR-transduced T cells will be re-infused back into adult leukaemia patients following lymphodepleting conditioning
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None