Clinical trial · Interventional
A Study of the Safety and Efficacy of EBV Specific T-cell Lines
A Phase I/II Open-label Study of the Safety and Efficacy of Epstein-Barr Virus Specific T-cell Lines for the Treatment of EBV Infection or EBV-related Lymphoproliferative Diseases
- 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 study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients suffering from high EBV viral titers not responding to standard of care therapies and to treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells or a T cell line derived from the patient's allogeneic donor (in the case of stem cell transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or partially matched related donor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus Infections | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Post-Transplant Lymphoproliferative Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A | Biological | — | UNRESOLVED |
| Group B | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autologous or allogenic (stem cell donor) T cells
- description
- Subjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor.
- interventionNames
- Biological: Group A
- type
- EXPERIMENTAL
- label
- Allogeneic "third party" T cells
- description
- Subjects receive a T-cell line from a matched or partially matched related donor.
- interventionNames
- Biological: Group B
Primary outcomes (1)
- measure
- Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Capacity to provide informed consent * Age ≥ 18 years old * Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma * ECOG of 2 or less Exclusion Criteria: * Medical condition requiring a corticosteroid dose greater than Prednisone 0.5mg/kg/day (or equivalent) at the time of the infusion. * Patient has received T-cell depleting antibodies or stem cell transplantation in the 28 days prior to proposed date of anti-EBV T-cell line infusion * Patient has received a solid organ transplant in the 3 months prior to proposed date of anti-EBV T-cell line infusion. * Pregnant or nursing females * Life expectancy of less than 3 months due to a condition unrelated to the EBV- related disease. * Active uncontrolled GVHD * Active uncontrolled SOT rejection episode DONOR ELIGIBILITY: An allogeneic donor must be a first-degree relative with at least 3/6 HLA compatibility, have consented to donate peripheral blood mononuclear cells, and fulfill the same criteria for stem cell donation according to the hospital's standard operating procedure.
References
Publications (0)
Data not yet available