Clinical trial · Interventional
Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)
Open-Label Individual Patient Study of Epstein-Barr Virus (EBV) Specific T-Cell Lines for the Treatment of a Lymphoproliferative Disease and Hemophagocytic Syndrome Associated With EBV
NCT06391814CI-TRIAL-00106242completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Associated Lymphoma | EBV-Related Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBV-specific T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single patient
- interventionNames
- Biological: EBV-specific T cells
Primary outcomes (1)
- measure
- Safety of a donor-derived EBV-specific T-cell line as assessed clinically by the lack of graft-versus-host host (GVHD).
- timeFrame
- 1 year
- description
- Evaluate the safety in terms of occurrence of graft-versus-host disease of a donor-derived allogeneic EBV-specific T-cell line generation and infusion in a patient suffering from a life-threatening EBV-related disease who received an allogeneic stem cell transplantation. Acute GVHD symptoms will be scored using MAGIC criteria using scores from 0 to IV, IV being the most severe involvement) on skin, liver and gastro-intestinal tract. Chronic GVHD symptoms will be score using the NIH consensus scale (0 to 3, 3 being the most severe) on the following organs skin, mouth, eyes, GI tract, liver, lungs, joints and fascia, and genital tract.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Capacity to provide informed consent 2. Age ≥ 18 3. Negative serum pregnancy test and use of effective contraception method. Exclusion Criteria: 1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath) 2. Pregnancy 3. Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome. 4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion.
References
Publications (0)
Data not yet available
No reference posted for this study.