At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
Posoleucel (formerly known as ALVR105) cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred Posoleuccel (ALVR105) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia
In Brief
A Phase 2 clinical trial evaluating Posoleucel (formerly known as ALVR105) cells and Placebo (visually identical to Posoleucel) for BK Virus Nephropathy and BK Virus Infection. Completed, enrolled 61 participants across 33 sites.
Detailed Summary
The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBK Virus Nephropathy, BK Virus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartMar 2021
Primary CompletionOct 2022
TodayJul 2026
First PostedOct 28, 2020
Enrollment StartMar 22, 2021
Primary CompletionOct 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.7 years ago
Interventions
Posoleucel (formerly known as ALVR105) cellsbiological
Infusion
Placebo (visually identical to Posoleucel)biological
Infusion