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

• Sponsor: AlloVir (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04933968
• Collaborator: (none)
• Enrollment: 77
• Locations: 20
• Arms: 2
• Anticipated Duration (Months): 27.3
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 21, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests [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) [Day 28]

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

Secondary Outcome Measures

1. Change in viral load [Up to Month 6]

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

2. Progression from URTI to LRTI [Day 10, Day 28]

   Proportion of patients with progression to LRTI

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare Hospitals DBA HonorHealth	Scottsdale	Arizona	United States	85260
2	City of Hope	Duarte	California	United States	91010
3	University of Florida - Division of Hematology & Oncology	Gainesville	Florida	United States	32610
4	University of Miami - Sylvester Cancer Center	Miami	Florida	United States	33136
5	Northside Hospital	Atlanta	Georgia	United States	30342
6	University of Iowa	Iowa City	Iowa	United States	52242
7	University of Kansas Cancer Center	Kansas City	Kansas	United States	64116.
8	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
9	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14203
10	University of North Carolina - Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
11	Duke University Medical Center	Durham	North Carolina	United States	27708
12	Wake Forest	Winston-Salem	North Carolina	United States	27157
13	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
14	University of Oklahoma - Health Science Center	Oklahoma City	Oklahoma	United States	73019
15	Medical University of South Carolina	Charleston	South Carolina	United States	29425
16	Vanderbilt University Cancer Center	Nashville	Tennessee	United States	37212
17	MD Anderson Cancer Center	Houston	Texas	United States	77030
18	MD Anderson	Houston	Texas	United States	77030
19	Virginia Commonwealth University	Richmond	Virginia	United States	23298
20	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

• AlloVir

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: AlloVir
• ClinicalTrials.gov Identifier: NCT04933968
• Other Study ID Numbers: P-106-001
• First Posted: Jun 22, 2021
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• 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: Infections; Communicable Diseases; Virus Diseases; Paramyxoviridae Infections

Study Results

No Results Posted as of Apr 19, 2022