Open Actively Recruiting

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

About

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, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
1 Year
Maximum Age
N/A

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.

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Study Stats
Protocol No.
22-001438
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04693637
For detailed technical eligibility, visit ClinicalTrials.gov.