Clinical trial · Interventional
Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants
A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients
- 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)
RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus. PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- infusions of EBV specific cytotoxic T lymphocytes
- description
- Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression
- interventionNames
- Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Primary outcomes (2)
- measure
- Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients
- timeFrame
- baseline to x weeks post infusion
- measure
- Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion criteria: * Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy * following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin * At least 4 weeks * Patients serologically hepatitis B and C positive may receive cytotoxic * T- lymphocytes (CTL) from donors who are serologically positive for the same virus * Must have an HLA identical or HLA haploidentical donor Exclusion * hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present) * Bilirubin less than 2.0 mg/dL * renal dysfunction * Creatinine clearance at greater than 50 mL/min * cardiac dysfunction * neurologic dysfunction * pulmonary dysfunction * patients developing EBV LPD who have a donor origin lymphoma * HIV-1 positive * Not capable of undergoing leukapheresis
References
Publications (0)
Data not yet available