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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2024
  • participants needed
    302
  • sponsor
    AlloVir
Updated on 20 April 2022

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.

Description

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.

Details
Condition Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Treatment Placebo, Posoleucel (ALVR105)
Clinical Study IdentifierNCT05305040
SponsorAlloVir
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥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)

Exclusion Criteria

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
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