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The TWO Study is a Phase IIb randomised controlled trial of regulatory T cells (Tregs) in renal transplantation, with the aim of facilitating the minimisation of drug immunosuppression. The first patient was recruited to the trial in late February, marking the start of an exciting phase of the study.

Patients receiving solid organ transplants must be maintained on multiple immunosuppressive drugs. These medicines are highly efficacious in the short term, but long-term outcomes are significantly limited by the serious and life-threatening side-effects that include life-threatening infection, malignancy, cardiovascular and metabolic disease. Long term drug immunosuppression together with treatment of the unwanted sequelae is a huge burden not only for the patient but also for the healthcare system, in terms of resource allocation and expenditure. It is clear therefore that a major goal of transplantation is the minimisation of pharmacological immunosuppression, whilst protecting the allograft from host immune responses. 

Tregs are a subset of T cells that act physiologically to prevent autoimmune disease and to limit an ‘overshoot’ in normal immune responses. A promising approach is to harness this regulatory ability to suppress the transplant rejection response. Having proven the safety and feasibility of Treg-based immunotherapy in the ONE Study (EudraCT number: 2013-002099-42), the TWO Study aims to demonstrate the efficacy of this treatment in a Phase IIb setting, with the goal of allowing minimisation of drug immunosuppression to a single agent by 6-months after kidney transplantation.

 For any questions, please contact the TWO Study team (

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