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

Principal Investigator

Trent Wang

Enrollment Status


Clinical Trial ID

Institutional Protocol # 20201042
National Clinical Trials Identifier NCT04390113

Clinical Trial Summary


Phase 3

Funding Agency/Sponsor




Enrollment Eligibility

Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate
in the study:
- Male or female ≥1 year of 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/or symptoms of cystitis.
2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
- At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is
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 posoleucel (ALVR105).
- Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative
- 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.

Contact Information

Phone Number 305-243-2647
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