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Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605484
Recruitment Status : Active, not recruiting
First Posted : October 28, 2020
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
BK Virus Nephropathy BK Virus Infection Biological: Posoleucel (formerly known as ALVR105) cells Biological: Placebo (visually identical to Posoleucel) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Posoleucel
Arm 1: Regimen A
 Biological: Posoleucel (formerly known as ALVR105) cells
Infusion
Experimental: Posoleucel and Placebo
Arm 2: Regimen B
 Biological: Posoleucel (formerly known as ALVR105) cells
Infusion

Biological: Placebo (visually identical to Posoleucel)
Infusion
Placebo Comparator: Placebo
Arm 3: Regimen A
 Biological: Placebo (visually identical to Posoleucel)
Infusion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 24 weeks ]
    Patients will be monitored for adverse events following each infusion and during the dosing period.


Secondary Outcome Measures :
  1. Change in BK viremia, Posoleucel compared to placebo [ Time Frame: 24 weeks ]
    Change in BK viral load in patients receiving Posoleucel compared to patients receiving placebo, based on mean +/- standard deviation of BK viral load as determined by the BK viral load assay performed at the central laboratory.

  2. Change in BK viremia, different dose regimens of Posoleucel compared to placebo [ Time Frame: 24 weeks ]
    Difference in mean BK viral load +/- standard deviation in Arm 1 versus placebo Arm 3, as compared to the difference in mean BK viral load in Arm 2 versus placebo Arm 3, -all as determined by the BK viral load assay performed at the central laboratory.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. (If a matching Posoleucel line is not available, the following patient data will be collected:

demographic data and human leukocyte antigen [HLA] type.)

  • 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.

  • A female patient is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:

    • She is a woman of non-childbearing potential (WONCBP) as defined in the protocol
    • She is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in the protocol during the study treatment period and for at least 90 days after the last dose of study treatment. The Investigator should evaluate the potential for contraceptive method failure.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605484


Locations
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Sponsors and Collaborators
AlloVir
Investigators
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Study Director: Francesca Cardarelli, MD AlloVir
More Information
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Publications:

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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT04605484    
Other Study ID Numbers: P-105-201
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Infections
Sepsis
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes