Summary

Eligibility
for people ages 1 year and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a Phase 3 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.

Official Title

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

Details

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

Keywords

Adenovirus Infection BK Virus Infection Cytomegalovirus Infections Epstein-Barr Virus Infections Human Herpes Virus-6 Infection JC Virus Infection Allogeneic Hematopoietic Cell Transplant ALVR105 Posoleucel Viralym-M Infections Communicable Diseases Virus Diseases Adenoviridae Infections Posoleucel (ALVR105)

Eligibility

You can join if…

Open to people ages 1 year and up

  • ≥1 year of age at the day of screening visit.
  • No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
  • 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
  • Matched or Mismatched unrelated donor
  • Use of umbilical cord blood as stem cell source
  • Ex vivo graft manipulation resulting in T cell depletion
  • Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

You CAN'T join 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California, San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stanford University not yet accepting patients
    Palo Alto California 94306 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AlloVir
ID
NCT05305040
Phase
Phase 2/3 research study
Study Type
Interventional
Last Updated