Gamma Delta T Cells in AML
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|ClinicalTrials.gov Identifier: NCT03885076|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 26, 2019
The Royal Marsden NHS Foundation Trust is committed to improving patient experience; this research is being undertaken to try to develop a novel treatment for patients with Acute Myeloid Leukaemia (AML). Researchers aim to develop a new therapy which uses a patients own immune cells called T cells to treat AML. The starting point with this study is to demonstrate whether sufficient numbers of T cells can be collected from the blood of patients with AML at various points throughout their treatment. Blood samples will be collected at the same time as the patient's bone marrow test.
If patients need further bone marrow tests during their course of treatment to assess the status of disease, the research team would ask that additional samples are taken at the same time as the bone marrow and blood will be collected at the same time as the routine blood draw.
Following collection of blood samples, they will be used to purify a population of blood cells called Gamma Delta T cells which have been shown to have a potential role in control of cancers. In addition the researchers plan to determine whether it is possible to put a novel receptor called a chimeric antigen receptor (CAR) to potentially directly target leukaemia cells. Currently this is only an exploratory study and none of the samples collected will be used for treatment and is only to assess whether or not this strategy is feasible. This may however lead on to studies in the future looking at the safety and effectiveness of this strategy. This hopefully will lead in the future to improvements in treatment and outcome for patients with AML.
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia||Procedure: Blood collection and bone marrow aspirate|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Assessing Feasibility of Expansion and Characterization of Gamma Delta T Cells From Peripheral Blood and Bone Marrow of Patients With Acute Myeloid Leukaemia as Starting Product for Generation of CD33-CD28 Gamma Delta T Cells|
|Actual Study Start Date :||August 23, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Acute myeloid leukaemia
Patients with Acute Myeloid Leukaemia (excluding M3) at presentation, remission or with refractory or relapsed disease. There is no intervention. This is an observational tissue collection study.
Procedure: Blood collection and bone marrow aspirate
Blood and bone marrow samples will be collected for the trial alongside routine tests.
- Percentage viable gamma delta T cells [ Time Frame: 6 months ]% of viable Vd2g T cells that can be generated from peripheral blood and bone marrow samples from AML patients at diagnosis and in AML patients with relapsed/refractory disease
- Transduced cells [ Time Frame: 6 months ]% of Vd2g T cells transduced with CD33-CD28 CAR.
- Target AML cells killed [ Time Frame: 6 months ]% of target AML cells killed by CD33-CD28 CAR Vd2g T cells
- Target monocytes killed [ Time Frame: 6 months ]% of target monocytes killed by CD33-CD28 CAR Vd2g T cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885076
|Contact: Ms C McCormack||020 8661 firstname.lastname@example.org|
|The Royal Marsden NHS Foundation Trust||Recruiting|
|Sutton, United Kingdom, SM2 5PT|
|Contact: Chloe E McCormack 020 8661 3202 email@example.com|
|Principal Investigator: Emma Nicholson|
|Principal Investigator:||Emma Nicholson||Royal Marsden NHS Foundation Trust|