The TWO Study: Transplantation Without Over-immunosuppression. A Phase IIb Trial of Regulatory T Cells in Renal Transplantation

Research summary

Patients receiving solid organ transplants must be maintained on drugs that suppress the immune system in order to prevent the immune system from rejecting the transplant. These medicines are highly efficacious, with one-year kidney transplant survival in the UK being > 95%. However long term outcomes are significantly limited by the serious and life-threatening side-effects of immunosuppressive drugs, which include enhanced rates of infection, malignancy and cardiovascular and metabolic disease such as heart attacks and diabetes. Long term maintenance on immunosuppressive drugs together with treatment of the unwanted side effects is a huge burden not only for the patient but also for the healthcare system, in terms of resource allocation and expenditure. Thus a major goal of future transplantation is to find ways to reduce the amount of immunosuppressive drugs used, whilst protecting the the kidney transplant from immune system damage. Regulatory T cells (Treg) are a subset of white blood cells that act to prevent autoimmune disease and to limit an ‘overshoot’ of normal immune responses to viruses. A promising approach is to use the regulatory ability of these cells to suppress the immune response causing rejection of the transplanted kidney. Having proven the safety and feasibility of Treg-based immunotherapy in the ONE Study (trial identifier: ONETreg1; EudraCT number: 2013-002099-42, co-sponsored by King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, REC number 13/SC/0568); the TWO Study aims to demonstrate the efficacy of this treatment, with the goal of allowing reduction of immunosuppression to a single drug by 6-months post-transplantation.

Principal Investigator

Dr Paul Harden

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

227287