Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
Chief Investigator:
Professor Persis Amrolia
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Immunotherapy with Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease after Solid Organ Transplant

ITREC is a multi-site, non-randomised phase I trial in children and adults with Post Transplant Lymphoproliferative Disease (PTLD) after solid organ transplant.  The Advanced Therapy Investigational Medicinal Products (ATIMP) in this study are autologous cryopreserved EBV specific cytotoxic T-cells (EBV CTL) transduced with a) the retroviral vector SFG-CNA12 encoding a calcineurin A mutant (CNA12) which confers resistance to tacrolimus and b) with the control retroviral vector SFG-CNA8 encoding a calcineurin A mutant (CNA8) that does not confer resistance to tacrolimus. 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. A total of 18 patients will be recruited at 3 participating sites.


Patients undergo leucapheresis for generation of the ATIMPs (CNA12 and CNA8 EBV-CTLs) which are manufactured in a laboratory at GOSH. The ATIMPs takes approximately 1 month to generate. Patients receive one intravenous injection of equal quantities of both ATIMPs. Other immunosuppressants (e.g. MMF) will be reduced, but tacrolimus will be maintained at therapeutic levels.

Key inclusion/exclusion criteria:

Adult and paediatric (age 1-70 years) solid organ transplant recipients with histologically proven B-lineage EBV+ post-transplant lymphoproliferative disease (PTLD) either de novo or resistant to Rituximab. Patients must be on immunosuppressant therapy with tacrolimus. Patients should not have fulminant disease, Burkitts lymphoma or Mature B-acute lymphoblastic leukaemia or T-lineage PTLD. Patients cannot have active hepatitis B, C or HIV infection, and bilirubin and creatinine must be of acceptable levels. 

Duration of recruitment:

2 years


The primary aim of the trial is to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (CNA12 EBV CTL) and compare their expansion/persistence with control CNA8 EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Secondary endpoints include Disease Response at 6 weeks post infusion, Relapse Rate at 1 and 2 yrs, and Disease Free Survival and Organ Graft Rejection at 6 months, 1 and 2 yrs post infusion.


Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
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