Clinical trial · Interventional
Autologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation
Adoptive Transfer of Autologous CMV Specific CD8+ T Cells After Allogeneic Stem Cell Transplantationas Treatment for CMV Reactivation: A Phase I/II Clinical Trial.
NCT01326273CI-TRIAL-00018175withdrawnPhase 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)
The investigators will assess whether the infusion of autologous CMV-specific T-cells at the time of CMV reactivation posttransplant will prevent worsening of CMV virus reactivation posttransplant to a level that warrants therapy with antiviral drugs (objectively assessed by looking at CMV virus copy number).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Stem Cell Transplantation | — | UNRESOLVED | — |
| Autologous CMV Specific CD8+ T Cells | — | UNRESOLVED | — |
| CMV Reactivation | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMV specific lymphocyte infusion | Procedure | — | UNRESOLVED |
| Haematology/Blood chemistry | Procedure | — | UNRESOLVED |
| Lymphopheresis | Procedure | — | UNRESOLVED |
| Peripheral blood for CMV DNA PCR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response to adoptive transfer of autologous CMV-specific CD8+ T-cells
- timeFrame
- Up to three years
- description
- Response to CMV-specific CD8+ T-cells administration will be measured and defined as a CMV DNA PCR\< 50 copies.
Secondary outcomes (4)
- measure
- The occurrence of subsequent CMV reactivations
- timeFrame
- Up to three years
- description
- The occurrence of subsequent CMV reactivations.
- measure
- Rate of complete response
- timeFrame
- Up to three years
- description
- The rate of complete response will be analyzed and compared to patients treated with anti-viral drugs only.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have received an allogeneic stem cell transplant from any donor, as treatment for a haematological malignancy. 2. HLAA0201 positive at one allele 3. CMV seropositive 4. The patient must be willing and capable of donating lymphocytes for CMVspecific CD8+ T cell selection using apheresis techniques 5. The patient must be in complete remission with no evidence of circulating blasts or other malignant cells 6. Patient must be fit to undergo leukapheresis 7. Patients must have signed an informed consent form before undergoing LP prior to alloSCT Indications for infusion of autologous CMV specific CD8+ Tcells: * Therapeutic: CMV disease following allogeneic stem cell transplantation * Preemptive: CMV reactivation (by CMV DNA PCR) * autologous CMV specific CD8+ T-cells must be infused into the patient no later than 72 following CMV reactivation. * Steroids should be withdrawn at least 1 week before the infusion of CMVspecific CD8+ T-cell * Patients must have signed an informed consent form before the infusion of autologous CMV specific CD8+ T-cells Exclusion Criteria: 1. Patient CMV seronegative 2. No informed consent 3. Patient positive at the time of LP for one of the following infectious agents: HIV, HBV, HCV,Syphilis, HTLV 1 and 2 4. Patient with circulating leukemic blasts at the time of LP Exclusion criteria for infusion of autologous CMV specific CD8+ T cells: Severe GvHD (grade IIII-V) requiring full dose immunosuppressive treatment
References
Publications (0)
Data not yet available
No reference posted for this study.