This is a multi-centre, non-randomised, open label Phase 1 clinical trial of Advanced Therapy
      Investigational Medicinal Products (ATIMPs) in adult and paediatric (age 1-70 years) solid
      organ transplant recipients with histologically proven B-lineage EBV+ post-transplant
      lymphoproliferative disease (PTLD).

      The ATIMPs for this study are autologous EBV CTL transduced with the (a) the retroviral
      vector SFG-CNA12 encoding a calcineurin A mutant (CNA12) that confers resistance to
      tacrolimus and (b) the retroviral vector SFG-CNA8 encoding a control calcineurin A mutant
      (CNA8).

      Following informed consent and registration to the trial, patients will undergo an
      unstimulated leucapheresis for generation of both ATIMPs. Patients will receive an equal dose
      of each ATIMP (10x7 CNA8+ or CNA12+ CTL/m2) which will be administered intravenously.

      Other immunosuppressants (e.g. MMF) will be reduced, but tacrolimus will be maintained at
      therapeutic levels.The trial will evaluate the safety of the ATIMPs in organ transplant
      recipients developing EBV+ PTLD and compare the persistence and frequency of circulating
      CNA12 and CNA8 CTL in the peripheral blood.

      Our hypothesis is that in the presence of ongoing immunosuppression with tacrolimus, CNA12
      CTL will show preferential expansion and prolonged persistence compared with CNA8 CTL. If
      successful this will result in durable clearance of PTLD without the need to reduce
      tacrolimus, thus reducing the risk of graft rejection.

      Patients will be followed up regularly during the interventional phase of the study until 1
      year post EBV CTL infusion. During the long-term follow-up phase of the study (from 1-5 years
      post EBV CTL infusion) patients will be followed up annually.