Clinical trial NCT04933968: Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
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 and Solid Organ Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
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)
Lead sponsor: AlloVir
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 17
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT 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 is Dose Escalation and Part B is Cohort Expansion.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
timeFrame: Day 1 up to 12 months
measure: Change in Viral Load From Baseline to Day 28 (Part B)
timeFrame: Baseline and Day 28 (Part B)
Secondary outcomes:
measure: Identify the Recommended Phase 2 Dose (RP2D) (Part A)
timeFrame: Day 1 up to 12 months
measure: Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
timeFrame: Baseline and Day 28
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)
timeFrame: Day 1 up to 12 months
measure: Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)
timeFrame: Day 1 and Month 6
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Hospitals DBA HonorHealth
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Gainesville
country: United States
facility: University of Florida - Division of Hematology & Oncology
state: Florida
city: Miami
country: United States
facility: University of Miami - Sylvester Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Lineberger Comprehensive Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.