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Status unknownNCT03885076Updated Jul 2, 2019

Gamma Delta T Cells in AML

An observational study in Acute Myeloid Leukemia, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Royal Marsden NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed AML or relapsed/refractory AML

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and 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.

    Procedure: Blood collection and bone marrow aspirate

Interventions

  • ProcedureBlood collection and bone marrow aspirate

    Blood and bone marrow samples will be collected for the trial alongside routine tests.

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What researchers measure

Primary outcomes

  1. Percentage viable gamma delta T cells

    % 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

    Time frame: 6 months

Secondary outcomes

  1. Transduced cells

    % of Vd2g T cells transduced with a CAR.

    Time frame: 6 months

  2. Target AML cells killed

    % of target AML cells killed by Gamma Delta CAR-T cells

    Time frame: 6 months

  3. Target monocytes killed

    % of target monocytes killed by Gamma Delta Car T cells

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
  • The Royal Marsden NHS Foundation Trust
    Sutton, SM2 5PT, United Kingdom
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03885076
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborators
TC Biopharm
Responsible party
Sponsor
First posted
Mar 21, 2019
Start date
Aug 23, 2018
Primary completion
Mar 2020 (estimated)
Completion
Mar 2021 (estimated)
Last update
Jul 2, 2019

Study contacts

Ms C McCormack
Contact
chloe.mccormack@rmh.nhs.uk
020 8661 3202
Emma Nicholson
principal investigator · Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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