Phase 3
N=26
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Adenovirus Infection · BK Virus Infection · Cytomegalovirus Infections · Epstein-Barr Virus Infections · Human Herpes Virus-6 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04693637 ↗Enrolled (actual)
26
Serious AEs
73.1%
Results posted
May 2024
Primary outcome: Primary: Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Posoleucel (ALVR105) (Biological)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- AlloVir
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease |
7 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease |
7 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV) |
1 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV |
— | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV) |
5 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV) |
1 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6) |
— | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV) |
— | — |
| SECONDARY Rates of Overall and Non-Relapse Mortality |
4; 0 | — |
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, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04693637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.