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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

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 28, 2020
Last Update Posted Date May 11, 2022
Actual Study Start Date  ICMJE March 22, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
Safety and tolerability [ Time Frame: 24 weeks ]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Patients will be monitored for adverse events following each infusion and during the dosing period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2022)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Change in BK viremia, Viralym-M compared to placebo [ Time Frame: 24 weeks ]
    Change in BK viral load in patients receiving Viralym-M 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.
  • Change in BK viremia, different dose regimens of Viralym-M 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 Viralym-M arm and the placebo arm in Cohort B-all as determined by the BK viral load assay performed at the central laboratory.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • BK Virus Nephropathy
  • BK Virus Infection
Intervention  ICMJE
  • Biological: Posoleucel (formerly known as ALVR105) cells
    Infusion
  • Biological: Placebo (visually identical to Posoleucel)
    Infusion
Study Arms  ICMJE
  • Experimental: Posoleucel
    Arm 1: Regimen A
    Intervention: Biological: Posoleucel (formerly known as ALVR105) cells
  • Experimental: Posoleucel and Placebo
    Arm 2: Regimen B
    Interventions:
    • Biological: Posoleucel (formerly known as ALVR105) cells
    • Biological: Placebo (visually identical to Posoleucel)
  • Placebo Comparator: Placebo
    Arm 3: Regimen A
    Intervention: Biological: Placebo (visually identical to Posoleucel)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2022)
60
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)
70
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04605484
Other Study ID Numbers  ICMJE P-105-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AlloVir
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AlloVir
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Francesca Cardarelli, MD AlloVir
PRS Account AlloVir
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP