Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
A study to evaluate 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.
- BK Virus Infection
- Hemorrhagic Cystitis
- Eligible Ages
- Over 1 Year
- Eligible Genders
- Accepts Healthy Volunteers
- Had an allogeneic HCT performed at least 21 days and not more than 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 (per Bedi scale). 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 Viralym-M cell line for infusion is available. (If a Viralym-M line is not available, the following patient data will be collected: demographic data and human leukocyte antigen [HLA] type.)
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent). - Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days of randomization. - Evidence of active Grade >2 acute graft versus host disease (GVHD). - Presence of uncontrolled or progressive bacterial or fungal infections (ie, evidence of bacteremia, fungemia, dissemination, and/or organ-specific infection not well controlled by present therapies). - Presence of progressive, uncontrolled viral infections (ie, evidence of viremia, dissemination, and/or organ-specific infection not well controlled by present therapies) not targeted by Viralym-M. - Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder. - Receipt of other investigational antiviral treatments (eg, brincidofovir) within 28 days prior to randomization and throughout the duration of the study. - Pregnant or lactating or planning to become pregnant.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Administered as 2-4 milliliter infusion, visually identical to Viralym-M||
|Administered as 2-4 milliliter infusion, visually identical to placebo||
The study hypothesis is that the administration of Viralym-M 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).