Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    125
  • sponsor
    AlloVir
Updated on 27 April 2022

Summary

A study to evaluate posoleucel (ALVR105); 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

The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).

Details
Condition BK Virus Infection, Hemorrhagic Cystitis
Treatment Placebo, Viralym-M, ALVR105 (Viralym-M), Posoleucel (ALVR105)
Clinical Study IdentifierNCT04390113
SponsorAlloVir
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must meet all of the following criteria in order to be eligible to participate
in the study
Diagnosed with HC based on the following criteria (all 3 criteria must be met)
Male or female ≥1 year of age
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year
prior to randomization
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3
consecutive laboratory values obtained on different days, and platelet count
>10,000/mm³ at the time of randomization
Clinical signs and/or symptoms of cystitis
Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6)
Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is
available

Exclusion Criteria

Evidence of active Grade >2 acute graft versus host disease (GVHD)
Pregnant or lactating or planning to become pregnant
Uncontrolled or progressive bacterial or fungal infections
Participants who meet any of the following criteria will be excluded from participation in
the study
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5
mg/kg/day or equivalent)
immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization
Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105)
Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative
disorder
Known or presumed pneumonia secondary to any organism that is not considered to be
well-controlled by antimicrobial therapy
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