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
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.
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.
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
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
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