Phase I study of transfer of effector memory T cells (Tem) following allogeneic stem cell transplantation. Short title- Transfer of Tem (ToTem)

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Healthy bone marrow produces blood cells, including those of the immune system that fight infections. All these blood cells originate from stem cells. When cancer affects a patient's bone marrow, it can no longer carry out its normal function. In order to restore healthy blood cell production and to fight the cancer, some patients are given healthy stem cells from a donor's bone marrow. Although bone marrow transplants can cure many patients, they can have serious side effects. One of these serious side effects, that affects about half of patients, is 'graft versus host disease' (GVHD). This happens because the bone marrow contains donor immune cells (the 'graft') that see the patient's healthy cells (the 'host') as foreign and attacks them. It mainly affects the tissues of the skin, the liver and the gut and can be life threatening.There are ways of preventing GVHD by using drugs that dampen down (suppress) the donor's immune cells in the patient's body, therefore stopping them from overreacting and attacking their body. However, the use of these immune supressing drugs has a major drawback because the immune system becomes weaker and cannot fight infections as well. These infections are sometimes very severe and can lead to patients dying.We have been working on new ways to prevent the donor's immune system causing GVHD in the patient's body without weakening it so much that it cannot fight infections as well. We have developed a new, simple way to take additional infection-fighting immune cells from the same donor's blood. When these are given to patients, they may help fight infections but not overreact and cause GVHD. If this works, it could be widely used at many hospitals across the country. This is because it uses equipment that is already used routinely by most bone marrow transplant centres.Therefore, this clinical trial aims to find out if giving patients these additional infection-fighting immune cells from the donor will reduce their chance of getting an infection without causing GVHD. Patients undergoing a bone marrow transplant will be asked if they want to give their consent to be part of the study. For these patients, we will give additional donor immune cells about one month after the transplant. They will also receive the standard GVHD prevention treatment. Different doses of the donor immune cells will be given to individual patients to work out which dose is best. All patients will be closely monitored for signs of GVHD or infection. They will also have blood tests to determine how well and quickly their immune systems recover. If the trial shows a possible benefit to patients, we will plan to extend the study to a larger number of patients. This will provide the necessary proof whether the treatment works in patients needing a bone marrow transplant.