Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Gamma Delta T Cells in AML

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 20, 2019
First Posted Date March 21, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date August 23, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03885076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 28, 2019)
  • Transduced cells [ Time Frame: 6 months ]
    % of Vd2g T cells transduced with a CAR.
  • Target AML cells killed [ Time Frame: 6 months ]
    % of target AML cells killed by Gamma Delta CAR-T cells
  • Target monocytes killed [ Time Frame: 6 months ]
    % of target monocytes killed by Gamma Delta Car T cells
Original Secondary Outcome Measures
 (submitted: March 20, 2019)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gamma Delta T Cells in AML
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with newly diagnosed AML or relapsed/refractory AML
Condition Acute Myeloid Leukemia
Intervention Procedure: Blood collection and bone marrow aspirate
Blood and bone marrow samples will be collected for the trial alongside routine tests.
Study Groups/Cohorts 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.
Intervention: Procedure: Blood collection and bone marrow aspirate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ms C McCormack 020 8661 3202 chloe.mccormack@rmh.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03885076
Other Study ID Numbers CCR4877
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Royal Marsden NHS Foundation Trust
Study Sponsor Royal Marsden NHS Foundation Trust
Collaborators TC Biopharm
Investigators
Principal Investigator: Emma Nicholson Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date June 2019