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Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

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ClinicalTrials.gov Identifier: NCT05179057
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
AlloVir

Study Description
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Brief Summary:
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Condition or disease Intervention/treatment Phase
Adenovirus Infection Drug: Posoleucel Drug: Placebo Phase 3

Detailed Description:
During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with option for blinded crossover to assess the safety and efficacy of posoleucel as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Posoleucel + SoC
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
 Drug: Posoleucel
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo Comparator: Placebo + SoC
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
 Drug: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with undetectable adenovirus infection [ Time Frame: 29 days ]
    Primary Efficacy

  2. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 34 weeks ]
    Primary Safety


Secondary Outcome Measures :
  1. Overall disease progression or non-relapse mortality [ Time Frame: 34 weeks ]
    Key Secondary Efficacy

  2. Mean area under the curve (AUC) AdV viral load [ Time Frame: 29 days ]
    Other Secondary Efficacy

  3. Proportion of participants who achieve AdV viremia <400 copies/mL [ Time Frame: 29 days ]
    Other Secondary Efficacy

  4. Time to undetectable AdV viremia (less than LLOQ) [ Time Frame: 34 weeks ]
    Other Secondary Efficacy

  5. Incidence of AdV disease recurrence [ Time Frame: 34 weeks ]
    Other Secondary Efficacy


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 1 year of age or older
  • Undergone allogeneic cell transplantation ≥21 days prior to dosing

  • Meet one of the below criteria:

    1. AdV viremia DNA ≥10,000 copies/mL, OR

    2. AdV viremia DNA results of ≥1,000 copies/mL, AND

      1. has absolute lymphocyte count <180/mm3, OR
      2. has received T cell depletion OR
      3. had a cord blood transplant.

Exclusion Criteria:

  • Grade >2 acute GVHD
  • Ongoing therapy with high-dose systemic corticosteroids
  • Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
  • Pregnant or lactating female unwilling to discontinue nursing prior to randomization
  • History of severe prior reactions to blood product transfusions.

NOTE: Other protocol-defined inclusion/exclusion criterion may apply.

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): NCT05179057


Contacts
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Contact: Chrissy Pelland +1 833-409-2281 ClinicalTrials@allovir.com

Locations
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Sponsors and Collaborators
AlloVir
More Information
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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT05179057    
Other Study ID Numbers: P-105-303
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
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
Keywords provided by AlloVir:
Allogeneic Hematopoietic Cell Transplant
Adenoviremia
Adenovirus
Stem Cell Transplant
 Posoleucel
ALVR105
Bone Marrow Transplant
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Adenoviridae Infections
Disease Attributes
 Pathologic Processes
DNA Virus Infections
Virus Diseases