Status:
TERMINATED
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Lead Sponsor:
AlloVir
Conditions:
Adenovirus Infection
BK Virus Infection
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adeno...
Detailed Description
This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV...
Eligibility Criteria
Inclusion
- Key
- Any age at the day of screening visit.
- No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
- Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing
- Meet one or more of the following criteria at the time of randomization:
- Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
- Haploidentical donor
- Matched or Mismatched unrelated donor
- Use of umbilical cord blood as stem cell source
- Ex vivo graft manipulation resulting in T cell depletion
- Received anti-thymocyte globulin or alemtuzumab (Campath-1H)
- Key
Exclusion
- History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
- Evidence of active Grade \>2 acute GVHD
- Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
- Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>1.0 mg/kg/day) within 24 hours prior to dosing
- Relapse of primary malignancy other than minimal residual disease
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT05305040
Start Date
March 24 2022
End Date
January 30 2024
Last Update
May 16 2024
Active Locations (88)
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1
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
3
City of Hope
Duarte, California, United States, 91010
4
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095