WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01621724 |
Recruitment Status :
Completed
First Posted : June 18, 2012
Last Update Posted : October 2, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | March 22, 2012 | ||||
First Posted Date ICMJE | June 18, 2012 | ||||
Last Update Posted Date | October 2, 2018 | ||||
Study Start Date ICMJE | April 2012 | ||||
Actual Primary Completion Date | May 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
WT1-specific immune responses of TCR-transduced T cells [ Time Frame: Up to 12 months per patient ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study | ||||
Official Title ICMJE | WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study | ||||
Brief Summary | WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid leukaemia. Patient's 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 patient's immune system's own T cells into T cells that the investigators hope will be much more effective at recognizing and killing leukaemia cells. |
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Detailed Description | This trial concerns a novel approach to generating leukaemia antigen-specific T cells for adoptive cellular therapy in HLA-A*0201 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Genetic: WT1 TCR-transduced T cells
Two patient cohorts: Cohort 1 (up to 6 patients) = ≤ 2 x 107/kg WT1 TCR-transduced T cells Cohort 2 (12 patients)= ≤ 108/kg WT1 TCR-transduced T cells |
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Study Arms ICMJE | Experimental: Single arm cohort study
WT1 TCR-transduced T cells
Intervention: Genetic: WT1 TCR-transduced T cells
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
7 | ||||
Original Estimated Enrollment ICMJE |
18 | ||||
Actual Study Completion Date ICMJE | May 2018 | ||||
Actual Primary Completion Date | May 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | General Inclusion Criteria:
Further disease specific inclusion criteria are detailed in Protocol Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01621724 | ||||
Other Study ID Numbers ICMJE | D-00272-CT2014001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Cell Medica Ltd | ||||
Study Sponsor ICMJE | Cell Medica Ltd | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Cell Medica Ltd | ||||
Verification Date | October 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |