Status:
COMPLETED
Posoleucel (ALVR105, Formerly 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
1+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovir...
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 Inclusion Criteria
- ≥1 year of age at the day of screening visit.
- Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
- Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
- 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
- Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR
- Use of umbilical cord blood as stem cell source
- Ex vivo graft manipulation resulting in T cell depletion
- Lymphocyte Count \<180/mm3 and/or cluster of differentiation 4 (CD4) Count \<50/mm3
- Key Exclusion Criteria:
- 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 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 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.
Exclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04693637
Start Date
January 15 2021
End Date
January 19 2023
Last Update
May 9 2024
Active Locations (16)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
4
Childrens National Medical Center
Northwest Rectangle, District of Columbia, United States, 20010