Clinical trial · Interventional
Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-transplant Lymphoproliferative Disease | — | UNRESOLVED | — |
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous EBV-CTL transduced with control vector SFG-CNA8 | Biological | — | UNRESOLVED |
| Autologous EBV-CTL transduced with vector SFG-CNA12 | Biological | — | UNRESOLVED |
| Leucapheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous EBV-CTL transduced with SFG-CNA12/SFG-CNA8
- description
- All patients will receive the autologous EBV CTL retrovirally transduced with with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8). For each patient two ATIMPs will be generated: * Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12 * Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8 An equal dose (10x7/m2) of CNA12+ EBV CTL and CNA8+ EBV CTL will be administered intravenously on day 0. While awaiting ATIMP generation, patients may receive a single dose of Rituximab and other immunosuppressants (e.g. MMF) will be reduced, but tacrolimus will be maintained at therapeutic levels.
- interventionNames
- Biological: Autologous EBV-CTL transduced with vector SFG-CNA12
- Biological: Autologous EBV-CTL transduced with control vector SFG-CNA8
- Procedure: Leucapheresis
Primary outcomes (2)
- measure
- Toxicity at 6 weeks post infusion
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. EBV viraemia at enrolment 3. On immunosuppression with tacrolimus 4. Agreement to have a pregnancy test and use of contraception for duration of trial (if applicable) 5. Written informed consent Exclusion Criteria: 1. Fulminant disease 2. Requirement for supplemental oxygen 3. Burkitt's lymphoma/Mature B-acute lymphoblastic leukaemia with IgH-Myc rearrangement 4. T-lineage PTLD 5. Bilirubin \> 3 x upper limit of normal 6. Creatinine \> 3 x upper limit of normal 7. Active hepatitis B, C or HIV infection 8. Women who are pregnant or breast-feeding 9. ECOG performance score ≥ 4 10. Inability to tolerate leucapheresis
References
Publications (0)
Data not yet available