Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04605484 | Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia | PHASE2 | COMPLETED | 61 | — | — | Mar 22, 2021 | Oct 20, 2022 | May 16, 2024 | 33 | United States |
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Posoleucel | EXPERIMENTAL | Arm 1: Regimen A |
| Posoleucel and Placebo | EXPERIMENTAL | Arm 2: Regimen B |
| Placebo | PLACEBO_COMPARATOR | Arm 3: Regimen A |
| Name | Type | Description |
|---|---|---|
| Posoleucel (formerly known as ALVR105) cells | BIOLOGICAL | Infusion |
| Placebo (visually identical to Posoleucel) | BIOLOGICAL | Infusion |
Inclusion Criteria: * Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment * At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available. * Capable of giving signed informed consent which includes compliance with th...