Clinical trial · Interventional
EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases
Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat EBV- Driven Lymphomas/ Diseases
NCT05688241CI-TRIAL-00086698ESPECTnot yet recruitingPhase 1 / Phase 2ClinicalTrials.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)
In this multi-center open-label, non-randomized phase I/II intervention study three consecutive doses of donor-derived EBV Tscm-CTLs will be administered to 10 patients with treatment-refractory EBV lymphoma, diseases or PTLDs. EBV Tscm-CTLs will derive from hematopoietic cell transplant (HCT) or third-party donors.
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 |
|---|---|---|---|
| EBV Lymphoma | — | UNRESOLVED | — |
| Post-transplant Lymphoproliferative Disease (PTLD) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor-derived ex-vivo expanded EBV Tscm CTL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: patients who undergo allogeneic HCT
- description
- Patients with EBV driven lymphomas (e.g., natural killer (NK)/T-cell lymphoma), with EBV complications (e.g. haemophagocytic lymphohistiocytosis (HLH), CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT.
- interventionNames
- Drug: Donor-derived ex-vivo expanded EBV Tscm CTL
- type
- EXPERIMENTAL
- label
- Group B: patients after HCT or SOT
- description
- EBV-driven PTLD that develop after a HCT or solid organ transplantation (SOT) and show decreased response to rituximab.
- interventionNames
- Drug: Donor-derived ex-vivo expanded EBV Tscm CTL
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Patients' inclusion criteria: * Group A: Patients with EBV driven lymphomas (e.g., NK/T-cell lymphoma), with EBV complications (e.g. HLH, CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT * Group B: EBV-driven PTLD that develop after a HCT or SOT For both groups: * All age groups * Negative pregnancy test in female patients of childbearing potential. * Signed written informed consent of patient or/and parents Patients' exclusion criteria: * Patients receiving anti-thymocyte globulin or Campath within 28 days of infusion * Patients with active, acute GvHD grades III-IV * Previous severe reaction to dimethylsulfoxide (DMSO) Donors' inclusion criteria: * EBV positive serology (VCA and Epstein-Barr nuclear antigen (EBNA) immunoglobulin G (IgG) positive) * Detectable interferon (IFN)-y-secreting T cells (\>100 SFC/10e6 PBMC) measured by Elispot to the EBV consensus peptide pool * Suitability for blood or HCT donation meeting requirements of local institutional guidelines * An informed consent for EBV Tscm CTL manufacturing * Age \> 18 years Donors' exclusion criteria: * Detectable IFN-y-secreting T-cells \<100 spot-forming cell (SFC)/10e6 PBMC measured by Elispot to EBV select * Unwilling and/or unable to donate, according to the donor center
References
Publications (0)
Data not yet available
No reference posted for this study.