BK Virus NephropathyPhase 2NCT04605484
Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
A Phase 2 study testing Posoleucel (formerly known as ALVR105) cells in people with BK Virus Nephropathy and BK Virus Infection, run by AlloVir at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Nephropathy, BK Virus Infection
- What is being tested?
- Posoleucel (formerly known as ALVR105) cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 33 sitesUnited States
- Study dates
- 22 Mar 2021to 20 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Undergone allogeneic hematopoietic cell transplantation
- Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
- Uncontrolled or progressive bacterial or fungal infections
- Known or presumed pneumonia
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
- Pregnant or lactating or planning to become pregnant.
- Weight <40 kg.
- Patients who received, or planned to receive abatacept or belatacept, within 3 months of screening
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Piedmont Hospital
Atlanta, Georgia, 30309
University of Maryland Medical Center
Baltimore, Maryland, 21201
John Hopkins Hospital
Baltimore, Maryland, 21287
Harvard Medical School - Brigham & Women's Hospital
Boston, Massachusetts, 02115
Erie County Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University Transplant Center
Chicago, Illinois, 60611
University of Cincinnati Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75204
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27708
Inova Fairfax Medical Center
Falls Church, Virginia, 22042
UPMC Pinnacle-Harrisburg Hospital
Harrisburg, Pennsylvania, 17101
Indiana University Hospital
Indianapolis, Indiana, 46202
University of Kansas Hospital
Kansas City, Kansas, 66160
Keck Medical Center of USC
Los Angeles, California, 90033
North Shore University Hospital
Manhasset, New York, 11030
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
Tulane University School of Medicine
New Orleans, Louisiana, 70112
NYU Langone Medical Center
New York, New York, 10016
Weil Medical College - NY Presbyterian Hospital
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94306
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02905
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California Davis Medical Center
Sacramento, California, 95817
University of California, San Francisco Medical Center
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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
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.
- Conditions
- BK Virus Nephropathy, BK Virus Infection
- Being tested
- Posoleucel (formerly known as ALVR105) cells, Placebo (visually identical to Posoleucel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posoleucel (formerly known as ALVR105) cellsBiological
Infusion
Placebo (visually identical to Posoleucel)Biological
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Posoleucel | Experimental | Arm 1: Regimen A Receives: Biological: Posoleucel (formerly known as ALVR105) cells |
| Posoleucel and Placebo | Experimental | Arm 2: Regimen B Receives: Biological: Posoleucel (formerly known as ALVR105) cells; Biological: Placebo (visually identical to Posoleucel) |
| Placebo | Placebo comparator | Arm 3: Regimen A Receives: Biological: Placebo (visually identical to Posoleucel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Week 24
Secondary outcomes (1)
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.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start22 Mar 2021
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BK Virus NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlloVir
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605484
- Sponsor's protocol ID
- P-105-201
- Status last verified
- Apr 2024
- First submitted
- 15 Oct 2020
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
PubMed 28783452Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
PubMed 38470444Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PubMed 39382091Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
PubMed 38597860
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04605484
- Acronym / sponsor ID
- P-105-201
- Conditions
- BK Virus Nephropathy, BK Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AlloVirIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Posoleucel | Experimental | Biological: Posoleucel (formerly known as ALVR105) cellsArm 1: Regimen A |
| Posoleucel and Placebo | Experimental | Biological: Posoleucel (formerly known as ALVR105) cells, Biological: Placebo (visually identical to Posoleucel)Arm 2: Regimen B |
| Placebo | Placebo comparator | Biological: Placebo (visually identical to Posoleucel)Arm 3: Regimen A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (8 listed)
- Undergone allogeneic hematopoietic cell transplantation
- Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
- Uncontrolled or progressive bacterial or fungal infections
- Known or presumed pneumonia
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posoleucel (formerly known as ALVR105) cellsInfusion | Biological | Posoleucel, Posoleucel and Placebo |
| Placebo (visually identical to Posoleucel)Infusion | Biological | Placebo, Posoleucel and Placebo |
Primary outcome
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Week 24
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.
1 secondary outcome
Change From Baseline in BK Viral Load
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28783452Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
- Background: PubMed 38470444Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
- Derived from this study: PubMed 39382091Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Derived from this study: PubMed 38597860Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
- Individual participant dataSharing planned: No
Related trials for BK Virus Nephropathy
RecruitingObservational study
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Nephropathy, Opportunistic Viral Infection
Not yet recruiting
Salivary Replication of BK Virus in Post-kidney Transplant
BK Virus, Salivary Replication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posoleucel (formerly known as ALVR105) cells in people with BK Virus Nephropathy and BK Virus Infection, run by AlloVir at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04605484, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.