Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
TerminatedPhase 3Results postedLast updated 8 May 2024
What this trial tests
Phase 3 trial testing Posoleucel in Adenovirus Infection in 57 participants. Terminated before completion.
Eligibility, any sex, with Adenovirus Infection. 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 Undetectable Adenovirus InfectionPrimary· Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower
Group
Value
95% CI
Posoleucel, Then Placebo
11
Placebo, Then Posoleucel
9
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)Primary· Up to 34 weeks
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failur
Any TEAE
Group
Value
95% CI
Posoleucel (Primary Study Period)
27
Placebo (Primary Study Period)
23
Posoleucel (Cross-over Period)
5
Placebo (Cross-over Period)
3
Any TEAE related to study treatment
Group
Value
95% CI
Posoleucel (Primary Study Period)
7
Placebo (Primary Study Period)
9
Posoleucel (Cross-over Period)
1
Placebo (Cross-over Period)
1
Any AESI
Group
Value
95% CI
Posoleucel (Primary Study Period)
6
Placebo (Primary Study Period)
9
Posoleucel (Cross-over Period)
1
Placebo (Cross-over Period)
2
Any SAE
Group
Value
95% CI
Posoleucel (Primary Study Period)
16
Placebo (Primary Study Period)
16
Posoleucel (Cross-over Period)
3
Placebo (Cross-over Period)
1
Any SAE related to study treatment
Group
Value
95% CI
Posoleucel (Primary Study Period)
1
Placebo (Primary Study Period)
1
Posoleucel (Cross-over Period)
1
Placebo (Cross-over Period)
1
Any TEAE leading to study treatment discontinuation
Group
Value
95% CI
Posoleucel (Primary Study Period)
2
Placebo (Primary Study Period)
1
Posoleucel (Cross-over Period)
0
Placebo (Cross-over Period)
2
Any TEAE leading to study discontinuation
Group
Value
95% CI
Posoleucel (Primary Study Period)
1
Placebo (Primary Study Period)
2
Posoleucel (Cross-over Period)
0
Placebo (Cross-over Period)
1
Any TEAE leading to death
Group
Value
95% CI
Posoleucel (Primary Study Period)
2
Placebo (Primary Study Period)
1
Posoleucel (Cross-over Period)
0
Placebo (Cross-over Period)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 34 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05101213 — Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus S
· Phase 1
· recruiting
NCT04722029 — Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
· Phase 1, PHASE2
· recruiting
NCT03475212 — Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
· Phase 1, PHASE2
· active not recruiting
Other AlloVir trials
Trials by the same sponsor.
NCT05305040 — Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transp
· Phase 2, PHASE3
· terminated
NCT04933968 — Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
· Phase 1, PHASE2
· terminated
NCT04605484 — Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
· Phase 2
· completed
NCT04390113 — Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
· Phase 3
· terminated
NCT04693637 — Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Trans
· Phase 2, PHASE3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AlloVir
Last refreshed: 8 May 2024
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/NCT05179057.