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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 : July 2, 2019
Sponsor:
Collaborator:
TC Biopharm
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:

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 patient's own immune cells called T cells to treat AML. In this study, numbers and properties of T cells which can be collected from the blood of patients with AML at various points throughout their treatment will be investigated. 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.

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Transduced cells [ Time Frame: 6 months ]
    % of Vd2g T cells transduced with a CAR.

  2. Target AML cells killed [ Time Frame: 6 months ]
    % of target AML cells killed by Gamma Delta CAR-T cells

  3. Target monocytes killed [ Time Frame: 6 months ]
    % of target monocytes killed by Gamma Delta Car T cells



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed AML or relapsed/refractory AML
Criteria

Inclusion Criteria:

  1. Patients over the age of 18 at time of diagnosis or at time of relapse of disease
  2. Patients with Acute Myeloid Leukaemia (excluding M3) at presentation, remission or with refractory or relapsed disease.
  3. Patients must have given informed written consent to participate in this study.

Exclusion Criteria:

  1. Uncontrolled systemic infection
  2. Currently receiving corticosteroids or other immune-suppressants treatment (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency)
  3. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months or throughout the trial
  4. Active, known or suspected autoimmune disease such as Ulcerative Colitis / Inflammatory bowel disease, Addison's disease
  5. Pregnancy or lactation before or during the study
  6. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study
  7. Patients with active Hepatitis B, C or HIV will be excluded from this study

Information from the National Library of Medicine

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


Contacts
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Contact: Ms C McCormack 020 8661 3202 chloe.mccormack@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Chloe E McCormack    020 8661 3202    chloe.mccormack@rmh.nhs.uk   
Principal Investigator: Emma Nicholson         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
TC Biopharm
Investigators
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Principal Investigator: Emma Nicholson Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03885076     History of Changes
Other Study ID Numbers: CCR4877
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms