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

• ClinicalTrials.gov Identifier: NCT04605484
• Recruitment Status: Active, not recruiting
• First Posted: October 28, 2020
• Last Update Posted: May 11, 2022
• Sponsor: AlloVir
• Information provided by (Responsible Party): AlloVir

Tracking Information

• First Submitted Date: October 15, 2020
• First Posted Date: October 28, 2020
• Last Update Posted Date: May 11, 2022
• Actual Study Start Date: March 22, 2021
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• BK Virus Nephropathy
• BK Virus Infection

Intervention

• Biological: Posoleucel (formerly known as ALVR105) cells
  Infusion
• Biological: Placebo (visually identical to Posoleucel)
  Infusion

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 5, 2022): 60
• Original Estimated Enrollment (submitted: October 22, 2020): 70
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04605484
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: AlloVir
• Original Responsible Party: Same as current
• Current Study Sponsor: AlloVir
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Francesca Cardarelli, MD; AlloVir

• PRS Account: AlloVir
• Verification Date: May 2022