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

NCT04933968 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: P-106-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 21

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) and solid organ transplant (SOT).

Conditions

Respiratory Tract Viral Infections; Human Metapneumovirus (hMPV) Infection; Parainfluenza (PIV) Infection; Respiratory Syncytial Viral (RSV) Infection; Influenza Infection

Keywords

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); Solid Organ Transplant (SOT)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)

  A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.

  Day 1 up to 12 months

• Change in Viral Load From Baseline to Day 28 (Part B)

  Change from Baseline in viral load as measured by quantitative PCR of nasal swab

  Baseline and Day 28 (Part B)

Secondary Outcomes (4)

• Identify the Recommended Phase 2 Dose (RP2D) (Part A)

  Day 1 up to 12 months

• Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)

  Baseline and Day 28

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)

  Day 1 up to 12 months

• Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)

  Day 1 and Month 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, visually identical to ALVR106

Biological: Placebo

ALVR106

ACTIVE COMPARATOR

ALVR106, visually identical to placebo

Biological: ALVR106

Interventions

ALVR106 BIOLOGICAL

Infusion, visually identical to placebo

ALVR106

Placebo BIOLOGICAL

Infusion, visually identical to ALVR106

Placebo

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
• Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
• Diagnosis of Upper or mild Lower Respiratory Tract Infection

You may not qualify if:

• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day)
• Infection by novel coronavirus disease 2019 (COVID-19)
• For HCT patients, evidence of Grade \>2 GVHD; and for SOT patients, any history or evidence of GVHD

Sponsors & Collaborators

• AlloVir: lead

Study Sites (21)

Scottsdale Healthcare Hospitals DBA HonorHealth

Scottsdale, Arizona, 85260, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of Florida - Division of Hematology & Oncology

Gainesville, Florida, 32610, United States

Location

University of Miami - Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 64116., United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

Location

University of North Carolina - Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Cancer Center

Nashville, Tennessee, 37212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.

  PMID: 31004020 BACKGROUND

• Papayanni PG, Koukoulias K, Kuvalekar M, Watanabe A, Velazquez Y, Ramos CA, Leen AM, Vasileiou S. T cell immune profiling of respiratory syncytial virus for the development of a targeted immunotherapy. Br J Haematol. 2023 Aug;202(4):874-878. doi: 10.1111/bjh.18933. Epub 2023 Jun 15.

  PMID: 37323051 DERIVED

MeSH Terms

Conditions

Infections; Paramyxoviridae Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Results are included for Part A only as no participants were enrolled into Part B due to early study termination.

Results Point of Contact

• Title: Senior Vice President
• Organization: AlloVir, Inc.

rriese@allovir.com

+1 617-433-2605

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 22, 2021
• Study Start: March 21, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Locations

US (21)