A Phase 2 interventional study of Posoleucel (formerly known as ALVR105) cells and Placebo (visually identical to Posoleucel) in BK Virus Nephropathy and BK Virus Infection, sponsored by AlloVir. Completed at 33 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by AlloVir · Phase 2, Interventional, and Treatment
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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.
AlloVir is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: Regimen A
Biological: Posoleucel (formerly known as ALVR105) cells
Arm 2: Regimen B
Biological: Posoleucel (formerly known as ALVR105) cells · Biological: Placebo (visually identical to Posoleucel)
Arm 3: Regimen A
Biological: Placebo (visually identical to Posoleucel)
Infusion
Infusion
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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.
Time frame: Day 1 to Week 24
Change From Baseline in BK Viral Load
BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.
Time frame: Baseline and Week 24
Participants were enrolled at 26 sites in the United States between March 2021 and October 2022.
| Milestone | Posoleucel (PSL) Group 1 | PSL Group 2 | Placebo |
|---|---|---|---|
| Started | 20 | 22 | 19 |
| Completed | 20 | 20 | 18 |
| Not completed | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
| Withdrew: Other | 0 | 1 | 0 |
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.
| Participants | PSL Group 1 | PSL Group 2 | Placebo |
|---|---|---|---|
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 17 | 17 | 16 |
BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.
| log10 copies/mL | PSL Group 1 | PSL Group 2 | Placebo |
|---|---|---|---|
| Change From Baseline in BK Viral Load | -0.830 (-2.08 to 0.11) | -0.520 (-3.55 to 0.52) | -0.330 (-2.08 to 0.27) |
Collected over Day 1 to Week 24. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PSL Group 1 | 0/20 (0%) | 2/20 (10%) | 16/20 (80%) |
| PSL Group 2 | 0/22 (0%) | 2/22 (9.1%) | 16/22 (72.7%) |
| Placebo | 0/19 (0%) | 0/19 (0%) | 16/19 (84.2%) |
| Event | PSL Group 1 | PSL Group 2 | Placebo |
|---|---|---|---|
| PyelonephritisInfections and infestations | 1/20 | 0/22 | 0/19 |
| Renal tuberculosisInfections and infestations | 1/20 | 0/22 | 0/19 |
| UrosepsisInfections and infestations | 1/20 | 0/22 | 0/19 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/20 | 0/22 | 0/19 |
| Transplant rejectionImmune system disorders | 0/20 | 1/22 | 0/19 |
| Enterococcal bacteraemiaInfections and infestations | 0/20 | 1/22 | 0/19 |
| ProteinuriaRenal and urinary disorders | 0/20 | 1/22 | 0/19 |
| Event | PSL Group 1 | PSL Group 2 | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 1/20 | 4/22 | 4/19 |
| COVID-19Infections and infestations | 3/20 | 2/22 | 3/19 |
| Blood creatinine increasedInvestigations | 3/20 | 1/22 | 1/19 |
| RashSkin and subcutaneous tissue disorders | 0/20 | 3/22 | 0/19 |
| NauseaGastrointestinal disorders | 1/20 | 0/22 | 2/19 |
| Oedema peripheralGeneral disorders | 0/20 | 1/22 | 2/19 |
| NasopharyngitisInfections and infestations | 0/20 | 0/22 | 2/19 |
| AnaemiaBlood and lymphatic system disorders | 2/20 | 0/22 | 0/19 |
| TachycardiaCardiac disorders | 2/20 | 0/22 | 0/19 |
| Transplant rejectionImmune system disorders | 2/20 | 0/22 | 0/19 |
Intent-to-Treat (ITT) Population: Included all randomized participants.
| Age, Continuous(years) | PSL Group 1 | PSL Group 2 | Placebo | Total |
|---|---|---|---|---|
| Median | 59.0 (21 to 75) | 54.0 (28 to 72) | 59.0 (47 to 75) | 58.0 (21 to 75) |
| Sex: Female, Male(Participants) | PSL Group 1 | PSL Group 2 | Placebo | Total |
|---|---|---|---|---|
| Female | 3 | 5 | 4 | 12 |
| Male | 17 | 17 | 15 | 49 |
| Ethnicity (NIH/OMB)(Participants) | PSL Group 1 | PSL Group 2 | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 2 | 9 |
| Not Hispanic or Latino | 18 | 17 | 17 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | PSL Group 1 | PSL Group 2 | Placebo | Total |
|---|---|---|---|---|
| Asian | 1 | 3 | 5 | 9 |
| Black or African American | 4 | 9 | 4 | 17 |
| White | 12 | 7 | 10 | 29 |
| Other | 3 | 2 | 0 | 5 |
| Missing | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | PSL Group 1 | PSL Group 2 | Placebo | Total |
|---|---|---|---|---|
| United States | 20 | 22 | 19 | 61 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Oct 2022, 18 months.
Results were first posted in May 2024, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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