ITREC
Research type
Research Study
Full title
Immunotherapy with Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease after Solid Organ Transplant
IRAS ID
225911
Contact name
Persis Amrolia
Contact email
Sponsor organisation
University College London
Eudract number
2017-001020-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 31 days
Research summary
Post-transplant lymphoproliferative disease (PTLD) is the commonest cancer seen in organ transplant patients. Current treatments for PTLD (including withdrawal of immunosuppression, the antibody Rituximab and chemotherapy) are often unsuccessful in controlling the disease and are associated with severe side effects including graft rejection. There is thus a need for safer, more effective treatments. Immunotherapy with immune (T) Cells directed against the virus EBV show promise for the treatment of EBV associated PTLD in other settings. However, organ transplant patients require immunosuppressive drugs such as Tacrolimus to prevent rejection and this may prevent EBV-specific T cells from working.
The ITREC study investigates whether T cells that have been genetically modified to work in the presence of Tacrolimus can be safely used to treat PTLD. We will take some of the patient’s T cells and modify them in a laboratory with a virus to insert the CNA12 gene which enables them to work in the presence of Tacrolimus. The other half of the cells will be modified with the CNA8 gene, which does not make them resistant to Tacrolimus (this will act as a control). We anticipate that, when given to patients with PTLD, the CNA12 cells will be able to work in the presence of Tacrolimus and will target the infected B cells in PTLD whereas the CNA8 T cells will not.
Patients will be closely monitored for side effects with regular tests/clinic visits over the first 14 days, and at regular intervals for the first year. The most likely side effect of the EBV-specific T cells is local inflammatory reactions (swelling and redness) at the site of the PTLD. In contrast to other treatments, we expect the risk of organ rejection to be very low because patients will continue to take Tacrolimus at their normal dose.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/2108
Date of REC Opinion
12 Mar 2019
REC opinion
Further Information Favourable Opinion