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

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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