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Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant

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: NCT04933968
Recruitment Status : Recruiting
First Posted : June 22, 2021
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

Brief Summary:
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT)

Condition or disease Intervention/treatment Phase
Respiratory Tract Viral Infections Human Metapneumovirus (hMPV) Infection Parainfluenza (PIV) Infection Respiratory Syncytial Viral (RSV) Infection Influenza Infection Biological: ALVR106 Biological: Placebo Phase 1 Phase 2

Detailed Description:

The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo.

This trial will consist of two parts:

Part A - Dose Escalation in Patients with Upper Respiratory Tract Infections (URTI) at High-Risk of Progression to Lower Respiratory Tract Infections (LRTI)

Part B - Recommended Phase 2 Dose (RP2D) cohort expansion in patients with URTIs at high-risk of progression to LRTIs

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, visually identical to ALVR106
Biological: Placebo
Infusion, visually identical to ALVR106

Active Comparator: ALVR106
ALVR106, visually identical to placebo
Biological: ALVR106
Infusion, visually identical to placebo




Primary Outcome Measures :
  1. Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests [ Time Frame: Up to Day 365 ]
    Number (%) of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug and number (%) of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0)

  2. Change in viral load (Part B) [ Time Frame: Day 28 ]
    Change from Baseline in viral load as measured by quantitative PCR of nasal swab


Secondary Outcome Measures :
  1. Change in viral load [ Time Frame: Up to Month 6 ]
    Change from Baseline in viral load as measured by quantitative PCR of nasal swab

  2. Progression from URTI to LRTI [ Time Frame: Day 10, Day 28 ]
    Proportion of patients with progression to LRTI

  3. Identify the recommended Phase 2 (RP2D) (Part A) [ Time Frame: Day 28 ]


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:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergone allogeneic, autologous, or cord blood stem cell transplantation at least 21 days prior to randomization
  • Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
  • Diagnosis of Upper Respiratory Tract Infection

Exclusion Criteria:

  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
  • Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days
  • Proven or suspected infection by novel coronavirus disease 2019 (COVID-19) within 28 days
  • Evidence of Grade >2 acute graft versus host disease (GVHD)
  • Receipt of another investigational antiviral treatment within 28 days
  • Donor lymphocyte infusion or other T cell therapies performed <21 days prior to randomization

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): NCT04933968


Contacts
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Contact: Amy Wheeler 833.409.2281 Clinicaltrials@allovir.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
AlloVir
Publications:
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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT04933968    
Other Study ID Numbers: P-106-001
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022

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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:
Respiratory virus
Hematopoietic Cell Transplant
Upper Respiratory Tract Infection
Bone Marrow Transplant
Human Metapneumovirus Infection
Parainfluenza
Respiratory Syncytial Virus (RSV)
Multi-virus specific T cells (VST)
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Paramyxoviridae Infections
Disease Attributes
Pathologic Processes
Mononegavirales Infections
RNA Virus Infections