Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ… (NCT03131934) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
United Kingdom18 participantsStarted 2019-05-31
Plain-language summary
This is an open label, non-randomised, multicentre Phase I to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their expansion/persistence with control EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).
Who can participate
Age range1 Year – 70 Years
SexALL
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Inclusion 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
✓. EBV viraemia at enrolment
✓. On immunosuppression with tacrolimus
✓. Agreement to have a pregnancy test and use of contraception for duration of trial (if applicable)
✓. Written informed consent
Exclusion criteria
✕. Fulminant disease
✕. Requirement for supplemental oxygen
✕. Burkitt's lymphoma/Mature B-acute lymphoblastic leukaemia with IgH-Myc rearrangement