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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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05179057
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

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.

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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 : January 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of participants with undetectable viremia (less than lower limit of quantitation [LLOQ]) at Day 29 [ Time Frame: 29 days ]
    Primary efficacy

  2. Incidence and severity of adverse events (AEs), including AE's of special interest (AESIs) [ Time Frame: 29 days ]
    Primary safety

  3. Incidence and severity of acute GVHD during the study [ Time Frame: 29 days ]
    Primary safety

  4. Incidence and severity of chronic GVHD during the study. [ Time Frame: 29 days ]
    Primary safety

  5. Incidence and severity of CRS during the study [ Time Frame: 29 days ]
    Primary safety


Secondary Outcome Measures :
  1. Proportion of participants with disease progression or non-relapse mortality by Day 29. [ Time Frame: 29 days ]
  2. Proportion of participants with undetectable viremia (less than LLOQ) at Day 29 in participants without AdV disease at screening. [ Time Frame: 29 days ]
  3. Proportion of participants with undetectable viremia (less than LLOQ) at Day 29 in participants with AdV disease at screening. [ Time Frame: 29 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • Has undergone allogeneic cell transplantation ≥21 days prior to randomization and demonstrated engraftment with an absolute neutrophil count >500/mm^3, AND has one of the following:

    1. AdV viremia DNA ≥10,000 copies/mL at screening, OR
    2. Two consecutive and rising AdV viremia DNA results of ≥1,000 copies/mL at screening, AND

      1. has absolute lymphocyte count <180/mm3, OR
      2. has received T cell depletion.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and refrain from donating sperm or eggs for at least 90 days after treatment completion.
  • Willing and able to provide signed informed consent.
  • Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.

Exclusion Criteria:

  • Grade >2 acute GVHD
  • Ongoing therapy with high-dose systemic corticosteroids
  • Grade 4 diarrhea
  • Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
  • Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation.
  • Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
  • Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to randomization.
  • Use of vasopressors within 7 days prior to randomization.
  • Use of any investigational antiviral agent, including brincidofovir, within 7 days prior to randomization.
  • Lactating female unwilling to discontinue nursing prior to randomization.
  • Severe allergy to any component of posoleucel or history of severe prior reactions to blood product transfusions.
  • Positive for SARS-CoV-2 virus at 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): NCT05179057


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

Locations
Show Show 17 study locations
Sponsors and Collaborators
AlloVir
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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: August 3, 2022
Last Verified: August 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
Keywords provided by AlloVir:
Allogeneic Hematopoietic Cell Transplant
Adenoviremia
Adenovirus
Stem cell transplant
Posoleucel
ALVR105
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Adenoviridae Infections
Disease Attributes
Pathologic Processes
DNA Virus Infections
Virus Diseases