Clinical trial · Interventional
Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).
Autologous EBV Specific CTLs for Prophylaxis and Therapy of EBV Lymphoma Post 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)
Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may already have a form of this disease. This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). These cells have been trained to attack and kill (cytotoxic) EB virus infected cells. We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells. This stimulation will train the T cells to kill EBV infected cells. We will then test the T cells to make sure they kill the EBV infected cells. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help prevent or cure EBV related cancers in solid organ transplant patients
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 |
|---|---|---|---|
| Epstein-Barr Virus Infections | — | UNRESOLVED | — |
| Lymphoproliferative Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous injection of EBV specific CTLs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Each patient will receive a Biological/Vaccine Intravenous injection of EBV specific CTLs
- interventionNames
- Biological: Intravenous injection of EBV specific CTLs
Primary outcomes (3)
- measure
- Generate autologous, EBV-specific, cytotoxic T cell lines (CTLs) from individuals receiving or having received a solid organ transplant (SOT).
- timeFrame
- pre-treatment
- measure
- Administer autologous, EBV-specific CTLs to patients, to determine the safety of intravenous injections in these individuals
- timeFrame
- 1 year
- measure
- Evaluate the antiviral and immunological efficacy of the infused CTLs
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients falling into one of the following categories: * Organ transplant recipients at high risk of developing LPD: * EBV seronegative recipients * Organ transplant recipients receiving OKT3 for immunosuppression * Organ transplant recipients with evidence of LPD * Organ transplant recipients with EBV DNA level \>1,000 copies * Age \<70 yrs old * Signed informed consent obtained from patient/guardian * CTLs available * Performance status; ECOG £ 2 * Creatinine \< 3X normal * Bilirubin \< 5X normal * AST \< 5X normal * Has not received any other investigational cellular therapies within the past 30 days. Exclusion criteria: * Patients with a severe intercurrent infection * Patients with life expectancy of less than 6 weeks * Patients receiving supplemental oxygen.
References
Publications (0)
Data not yet available