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Clinical Trial 20778

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04390113

Phase: Phase III
Prinicipal Investigator: Faramand, Rawan

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Overview

Study Title

Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

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.

Objective

Primary: The primary objective is to compare the time to resolution of macroscopic hematuria in recipients of Viralym-M (also known as ALVR-105) to that in patients receiving placebo. Secondary: The key secondary objective is to compare the time to resolution of bladder pain as measured by Clinical Outcome Assessments (COAs) in recipients of Viralym-M to that in patients receiving placebo. Other secondary objectives include comparisons of the following in recipients of Viralym-M and patients receiving placebo: * To assess number of days in the hospital (for any reason including, but not limited to, HC) over the 24-week study period * To assess the incidence and severity of acute GVHD and CRS over the 24-week study period * To assess time to resolution of viremia for all target viruses over the 24-week study period (only for patients with detectable viremia at baseline) * To assess average daily bladder pain (11-point numeric rating scale [NRS]) over the 6-week period from randomization

Treatments

Therapies

Therapy (NOS)

Medications

Viralym-M/Placebo ()

Inclusion Criteria

  • 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):
  • Clinical signs and symptoms of cystitis, including dysuria, lower abdominal pain, and/or other bladder-associated pain or spasms.
  • Grade > 3 hematuria, defined as macroscopic hematuria with visible clots.
  • 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

  • Exclusion Criteria

  • 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 > 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.

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