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

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ClinicalTrials.gov Identifier: NCT04605484
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
AlloVir

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; Viralym-M) cells Biological: Placebo (visually identical to Posoleucel) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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, 3-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred ALVR105 (Viralym-M) 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 : June 2022
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Posoleucel
Cohort A, Arm 1: Regimen A
Biological: Posoleucel (formerly known as ALVR105; Viralym-M) cells
Infusion

Experimental: Posoleucel and Placebo
Cohort A, Arm 2: Regimen B
Biological: Posoleucel (formerly known as ALVR105; Viralym-M) cells
Infusion

Biological: Placebo (visually identical to Posoleucel)
Infusion

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

Experimental: Cohort B, Arm 1
Following interim analysis, optimal posoleucel dosing regimen from Cohort A
Biological: Posoleucel (formerly known as ALVR105; Viralym-M) cells
Infusion

Placebo Comparator: Cohort B, Arm 2
Same dosing interval as Cohort B, Arm 1
Biological: Placebo (visually identical to Posoleucel)
Infusion




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 (ALVR105) compared to placebo [ Time Frame: 24 weeks ]
    Change in BK viral load in patients receiving Posoleucel (ALVR105) 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 (ALVR105) compared to placebo [ Time Frame: 24 weeks ]
    Difference in mean BK viral load +/- standard deviation in Cohort A Arm 1 versus placebo Arm 3, as compared to the difference in mean BK viral load in Cohort A Arm 2 versus placebo Arm A3, as well as the difference in mean BK viral load between Posoleucel (ALVR105) arm and the placebo arm in Cohort B-all as determined by the BK viral load assay performed at the central laboratory.



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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 (Viralym-M) cell line for infusion is available. (If a matching Posoleucel (Viralym-M) 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, belatacept, sirolimus or everolimus within 3 months of screening

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


Contacts
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Contact: Kenny Kamineni 833-409-2281 clinicaltrials@allovir.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
AlloVir
Investigators
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Study Director: Francesca Cardarelli, MD AlloVir
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: August 6, 2021
Last Verified: July 2021
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