Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390113
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
AlloVir

Brief Summary:
A study to evaluate ALVR105 (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.

Condition or disease Intervention/treatment Phase
BK Virus Infection Hemorrhagic Cystitis Biological: ALVR105 (Viralym-M) Biological: Placebo Phase 3

Detailed Description:
The study hypothesis is that the administration of 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2022

Arm Intervention/treatment
Placebo Comparator: Placebo
Administered as 2-4 milliliter infusion, visually identical to ALVR105 (Viralym-M)
Biological: Placebo
Administered as 2-4 milliliter infusion, visually identical to ALVR105 (Viralym-M)

Experimental: ALVR105 (Viralym-M)
Administered as 2-4 milliliter infusion, visually identical to placebo
Biological: ALVR105 (Viralym-M)
Administered as 2-4 milliliter infusion, visually identical to placebo




Primary Outcome Measures :
  1. Time until urine is visually clear of hematuria [ Time Frame: Until event occurrence through week 24 ]

Secondary Outcome Measures :
  1. Time until bladder pain is resolved [ Time Frame: Until event occurrence through week 24 ]
  2. Days in the hospital for any reason [ Time Frame: Until event occurrence through week 24 ]
  3. Time to resolution for target all viruses [ Time Frame: Until event occurrence through week 24 ]
  4. Average daily bladder/lower abdominal pain [ Time Frame: Until event occurrence through week 6 ]
  5. Incidence and severity of acute graft versus host disease and cytokine release syndrome [ Time Frame: Until event occurance through week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

Participants must meet all of the following criteria in order to be eligible to participate in the study:

  • Male or female of any 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.
  • Diagnosed with HC based on the following criteria (all 3 criteria must be met):

    1. Clinical signs and symptoms of cystitis, including dysuria, lower abdominal pain, and/or other bladder-associated pain or spasms.
    2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
    3. Viruria of >5 log10 copies/mL of at least 1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
  • At least 1 identified, suitably matched ALVR105 cell line for infusion is available.

Key Exclusion Criteria

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).
  • Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies <28 days before randomization.
  • Evidence of active Grade >2 acute graft versus host disease (GVHD).
  • Uncontrolled or progressive bacterial or fungal infections.
  • Uncontrolled or progressive viral infections not targeted by 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.
  • Pregnant or lactating or planning to become pregnant.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390113


Contacts
Layout table for location contacts
Contact: Kyle Herbert +1 833-409-2281 ClinicalTrials@allovir.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
AlloVir
Publications:
Layout table for additonal information
Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT04390113    
Other Study ID Numbers: AVM-003-HC
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlloVir:
Allogeneic Hematopoietic Cell Transplant
ALVR105
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis
Urinary Bladder Diseases
Urologic Diseases