NCT03131934CompletedEarly phase 1
Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 24 Apr 2017
- Start date
- 31 May 2019
- Primary completion date
- 30 Jun 2020
- Lead sponsor
- University College, London
- Diseases
- Childhood cancers
- NCT number
- NCT03131934
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 4
- From 31 May 2019 to the primary completion date, 30 Jun 2020
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Fulminant disease
- Active hepatitis B, C or HIV infection
Lab values
- Bilirubin \> 3 x upper limit of normal
- Creatinine \> 3 x upper limit of normal
Other
- Requirement for supplemental oxygen
- Burkitt's lymphoma/Mature B-acute lymphoblastic leukaemia with IgH-Myc rearrangement
- T-lineage PTLD
- Women who are pregnant or breast-feeding
- ECOG performance score ≥ 4
- Inability to tolerate leucapheresis
Who the study is looking for
- 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
Age in the registry: 1 year to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.