Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
CompletedPhase 2Results postedLast updated 16 December 2020
What this trial tests
Phase 2 trial testing CMV-pp65 CTLs in Cytomegalovirus in 58 participants. Completed in 11 December 2019.
Eligibility, any sex, with Cytomegalovirus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a Complete ResponsePrimary· 3 years
The endpoint of this study is complete response, defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. The evaluation of treatment efficacy will be assessed separately for patients receiving CMV specific T cells from their transplant donor.
Group
Value
95% CI
Group I
8
Group I
50
Number of Participants With ToxicitiesPrimary· 3 years
For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed.
Group
Value
95% CI
Group I
58
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to see how well transfusions of T-cells work in treating CMV. T-cells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
· recruiting
NCT06958796 — Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
· Phase 4
· recruiting
NCT05664126 — Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Ce
· Phase 2
· recruiting
NCT05575492 — A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Year
· Phase 1, PHASE2
· active not recruiting
NCT03665675 — Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
· EARLY_PHASE1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 16 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01646645.