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Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)

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ClinicalTrials.gov Identifier: NCT05305040
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

Study Description
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Brief Summary:
This is a Phase 3 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

Condition or disease Intervention/treatment Phase
Adenovirus Infection BK Virus Infection Cytomegalovirus Infections Epstein-Barr Virus Infections Human Herpes Virus-6 Infection JC Virus Infection Biological: Posoleucel (ALVR105) Biological: Placebo Phase 2 Phase 3

Detailed Description:

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.

There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
 Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Other Name: Viralym-M
Placebo Comparator: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
 Biological: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)


Outcome Measures
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Primary Outcome Measures :
  1. Number of clinically significant infections or episodes of end-organ disease [ Time Frame: Through Week 14 ]

Secondary Outcome Measures :
  1. Number of clinically significant infections or episodes of end-organ disease [ Time Frame: Through Week 26 ]
  2. Number of clinically significant infections or episodes of end-organ disease due to each virus [ Time Frame: Through Week 14 and 26 ]
  3. Mean area under the curve (AUC) viral load [ Time Frame: Through Week 14 and 26 ]
  4. Incidence of Adverse Events [ Time Frame: Through Week 26 ]
  5. Overall and Non-Relapse Mortality [ Time Frame: Through Week 26 ]

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

Key Inclusion Criteria:

  • ≥1 year of age at the day of screening visit.
  • No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
  • Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment

  • Meet one or more of the following criteria at the time of randomization:

    • Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
    • Haploidentical donor
    • Matched or Mismatched unrelated donor
    • Use of umbilical cord blood as stem cell source
    • Ex vivo graft manipulation resulting in T cell depletion
    • Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

Key Exclusion Criteria:

  • History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
  • Evidence of active Grade >2 acute GVHD
  • Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
  • Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
  • Relapse of primary malignancy other than minimal residual disease

Note: Other protocol defined Inclusion/Exclusion criteria 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): NCT05305040


Contacts
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Contact: Dee Rodriguez 833-409-2281 ClinicalTrials@allovir.com

Locations
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Sponsors and Collaborators
AlloVir
More Information
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Publications:
Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.

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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT05305040    
Other Study ID Numbers: P-105-202 Phase 3
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 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
ALVR105
Posoleucel
Viralym-M
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Adenoviridae Infections
Cytomegalovirus Infections
Epstein-Barr Virus Infections
 Disease Attributes
Pathologic Processes
DNA Virus Infections
Herpesviridae Infections
Tumor Virus Infections