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

NCT04693637 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: P-105-202 Phase 2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 16

Brief Summary

This is a Phase 2 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.

Conditions

Adenovirus Infection; BK Virus Infection; Cytomegalovirus Infections; Epstein-Barr Virus Infections; Human Herpes Virus-6 Infection; JC Virus Infection

Keywords

Allogeneic Hematopoietic Cell Transplant; Posoleucel; ALVR105; Viralym-M

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease

  The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

  Through Week 14

Secondary Outcomes (8)

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease

  Through Week 26

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)

  Through Week 26

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV

  Through Week 26

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)

  Through Week 26

• Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)

  through Week 26

Study Arms (1)

Posoleucel (ALVR105)

EXPERIMENTAL

Administered as 2-4 milliliter infusion

Biological: Posoleucel (ALVR105)

Interventions

Posoleucel (ALVR105) BIOLOGICAL

Administered as 2-4 milliliter infusion

Posoleucel (ALVR105)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥1 year of age at the day of screening visit.
• Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
• 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
• Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Lymphocyte Count \<180/mm3 and/or cluster of differentiation 4 (CD4) Count \<50/mm3

You may not qualify if:

• 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

Sponsors & Collaborators

• AlloVir: lead

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Childrens National Medical Center

Northwest Rectangle, District of Columbia, 20010, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Hospital

Westwood, Kansas, 66205, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stony Brook University Hospital Cancer Center

Stony Brook, New York, 11794, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (4)

• 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.

  BACKGROUND

• Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

  PMID: 28783452 BACKGROUND

• Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.

  PMID: 38470444 BACKGROUND

• Dadwal SS, Bansal R, Schuster MW, Yared JA, Myers GD, Matzko M, Adnan S, McNeel D, Ma J, Gilmore SA, Vasileiou S, Leen AM, Hill JA, Young JH. Final outcomes from a phase 2 trial of posoleucel in allogeneic hematopoietic cell transplant recipients. Blood Adv. 2024 Sep 10;8(17):4740-4750. doi: 10.1182/bloodadvances.2023011562.

  PMID: 38593233 DERIVED

MeSH Terms

Conditions

Adenoviridae Infections; Cytomegalovirus Infections; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Herpesviridae Infections; Tumor Virus Infections

Results Point of Contact

• Title: Michelle Matzko, MD, PhD
• Organization: AlloVir, Inc

mmatzko@allovir.com

617-433-2605

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: May 9, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)