Immunotherapy with CD25/71 Allodepleted T-cells (ICAT)
Research type
Research Study
Full title
Adoptive Immunotherapy with CD25/71 allodepleted donor T cells to improve immunity after unrelated donor stem cell transplant (ICAT)
IRAS ID
131126
Contact name
Persis Amrolia
Contact email
Sponsor organisation
University College London
Eudract number
2013-000872-14
Clinicaltrials.gov Identifier
Research summary
Many patients with Leukaemia are curable by stem cell transplant (SCT) from a matched unrelated donor (MUD). When such transplants are done we have to remove the immune T-cells from the graft to prevent a complication called graft versus host disease (GVHD) which occurs when “alloreactive” T-cells from the donor attack the patient. However this means that patients have very little immunity for many months after SCT resulting in high rates of viral complications affecting the lungs, liver, eyes and other organs. These complications are associated with significant impacts on patients health and well-being, death rate and is associated with economic burden. We have investigated an approach to improve immunity after SCT by giving back T-cells from the donor, having specifically removed the cells that cause GVHD, whilst leaving the ones that fight viruses. The aim of this study is to determine whether giving such “allodepleted” donor T-cells can improve immunity in patients after MUD SCT. Patients will undergo a 9/10 or 10/10 HLA-matched SCT as per standard local practice. Following this the trial will compare a study arm where patients will be given allodepleted donor T-cells and a control arm receiving continued standard of care. Patients will be identified, consented and treated at sites in the UK. Patients who are randomised to receive the allodepleted donor T-cells will receive 3 doses of the cells at monthly intervals from day 30 post-SCT. Patients will be followed up until 12 months post-transplant and the trial will compare the recovery of immunity in the study and control groups. This approach may be of major clinical benefit to patients undergoing SCT by reducing viral complications.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0322
Date of REC Opinion
17 Sep 2013
REC opinion
Further Information Favourable Opinion