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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT04605484
Study groupRoleWhat they receive
PosoleucelExperimentalArm 1: Regimen A
Receives: Biological: Posoleucel (formerly known as ALVR105) cells
Posoleucel and PlaceboExperimentalArm 2: Regimen B
Receives: Biological: Posoleucel (formerly known as ALVR105) cells; Biological: Placebo (visually identical to Posoleucel)
PlaceboPlacebo comparatorArm 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.

  1. 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)

  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.

  1. First posted28 Oct 2020
  2. Study start22 Mar 2021
  3. Primary completion20 Oct 2022
  4. Study completion20 Oct 2022

Resources

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)
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
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 28783452

  • Chandraker 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 38470444

  • Wajih 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 39382091

  • Vasileiou 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

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.

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