Phase I study of transfer of effector memory T cells (Tem) following allogeneic stem cell transplantation
Description
Design:
ToTem is a national phase I trial studying the transfer of effector memory T cells (Tem) in patients eligible for allogeneic stem cell transfer. A Bayesian Time-to-Event Continual Reassessment Method (CRM) will be used to determine the safety and maximum tolerated dose (MTD) of the Tem cells, CD62L- Tem.
Treatment:
Eligible patients and HLA-identical sibling donors will be registered prior to transplant, and the donors will undergo an additional steady state apheresis for the collection of T cells and selection of the Tem cells. The donor Tem cells, at the required dose, will be given as a single infusion between day 24-32 following the allo-SCT, and patients closely followed up for up to 72 days post the infusion. They will also have regular visits at 3, 6, 9 and 12 months following allo-SCT.
Key inclusion/exclusion criteria:
Patients must be from 16 to less than 70 years of age with a diagnosis of either Severe aplastic anaemia, Primary immune deficiency or a Haematological cancer with a complete or partial response/remission, suitable for HLA-identical sibling transplant using a standard alemtuzumab-based conditioning regimen with calcineurin-inhibitor based immunoprophylaxis. They must not have prior or active acute pattern GvHD of any grade, or a primary/secondary graft failure.
Duration of recruitment:
Anticipated 30 months recruitment and a minimum of 12 months post-STC. So the study is expected to last at least 3 years.
Aim
To determine the feasibility and safety of the transfer of donor Tem cells following allogeneic stem cell transplantation.