ToTem
Research type
Research Study
Full title
Phase I study of transfer of effector memory T cells (Tem) following allogeneic stem cell transplantation.
IRAS ID
252908
Contact name
Ronjon Chakraverty
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, days
Research summary
Healthy bone marrow produces blood cells, including infection-fighting immune cells. These blood cells originate from stem cells. In cancer, the bone marrow can no longer function properly. 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 this can cure many patients, it can have serious side effects, including ‘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. Drugs that prevent GvHD by suppressing the donor’s immune cells in the patient’s body renders the immune system weak and unable to fight infections. These infections are sometimes very severe and can lead to patients dying.
This trial aims to find out if giving patients additional infection fighting immune cells from the donor (Tem cells) will reduce their chance of getting an infection without causing GvHD.
Patients will receive 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. Patients will be followed up for 12 months post treatment.
The study will recruit a maximum of 18 patients. The study will be conducted at NHS hospitals and is expected to last 22 months.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0870
Date of REC Opinion
7 Jun 2019
REC opinion
Favourable Opinion