Clinical Trial 20778

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

Phase: Phase III
Principal 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 > 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. Platelet transfusions are permitted.

Diagnosed with HC based on the following criteria (all 3 criteria must be met):

Clinical signs and/or symptoms of cystitis, such as dysuria, urinary frequency, urinary urgency, lower abdominal pain or tenderness, and/or bladder pain, tenderness, or spasms.

Bedi Grade > 3 hematuria, defined as macroscopic hematuria with visible clots.

Viruria > 1 target virus (ie, BKV, JCV, EBV, AdV, CMV, and/or HHV-6).

At least 1 identified, suitably matched PSL 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 PSL.

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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