Clinical trial · Interventional
Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation
Prospective, Open, Randomized, Two-arm, Controlled, Multicenter Clinical Phase I/IIa Trial to Evaluate the Safety and Efficacy of Adoptive Immunotherapy With Allogeneic CMV/EBV Specific, Peptide Stimulated T-cells (CD3+) for Prevention or Preemptive Therapy of Reactivation of CMV and/or EBV in Patients After Allogeneic, HLA Identical Stem Cell Transplantation
- 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 patients after allogeneic stem cell transplantation reactivation of latent herpesviruses such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening complication requiring antiviral treatment. The underlying problem is a severe suppression of the donors immune system after transplantation into the patient. Herpesviruses such as CMV and EBV persist after primary infection life long in the host and therefore require constant immunological control. This control is largely provided by the T-cell compartment of the immune system. After allogeneic stem cell transplantation the T-cell compartment requires a long time for its reconstitution since only a small fraction of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell control. This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a phase I study to demonstrate that these in vitro generated T-cells can be applied safely in this patient population. The study also aims at demonstrating the efficacy of CMV/EBV specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host disease and that they successfully prevent reactivation of CMV and EBV after adoptive transfer in patients after allogeneic stem cell transplantation.
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 |
|---|---|---|---|
| Patients Undergoing Allogeneic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMV/EBV specific T-cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adoptive transfer of CMV/EBV specific T-cells
- description
- Repetitive adoptive T-cell transfer starting at day 30 after allogeneic stem cell transplantation.
- interventionNames
- Biological: CMV/EBV specific T-cell
- type
- NO_INTERVENTION
- label
- Control
- description
- Observation only.
Primary outcomes (1)
- measure
- Toxicity of adoptive transfer of CMV/EBV specific T-cells
- timeFrame
- 1-28 days after adoptive T-cell transfer
- description
- Assessment of acute transfusion toxicity within 24 hours after adoptive T-cell transfer. Assessment of the development of acute transfusion associated acute graft versus host disease (GvHD) within 28 days after adoptive T-cell transfer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for allogeneic stem cell transplantation * HLA identical donor, related or unrelated, 10/10 match * Stem cell source: G-SCF mobilized peripheral blood stem cells * Presence of at least one HLA allele: A0101, A0201, B0702, B0801, B3501, C0702 * Positive EBV serology of the donor * Positive CMV serology of the donor * Adequate contraception Exclusion Criteria: * Donor CMV seronegative * Donor EBV seronegative * Stem cell source: bone marrow or cord blood * Alemtuzumab for conditioning * Sorror Score \>3 * Pregnancy
References
Publications (1)
- DERIVEDGerbitz A, Gary R, Aigner M, Moosmann A, Kremer A, Schmid C, Hirschbuehl K, Wagner E, Hauptrock B, Teschner D, Roesler W, Spriewald B, Tischer J, Moi S, Balzer H, Schaffer S, Bausenwein J, Wagner A, Schmidt F, Brestrich J, Ullrich B, Maas S, Herold S, Strobel J, Zimmermann R, Weisbach V, Hansmann L, Lammoglia-Cobo F, Remberger M, Stelljes M, Ayuk F, Zeiser R, Mackensen A. Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation: results from the randomized phase I/IIa MULTIVIR-01 study. Front Immunol. 2023 Oct 30;14:1251593. doi: 10.3389/fimmu.2023.1251593. eCollection 2023. PMID 37965339