Open Actively Recruiting
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
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.
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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
- UCLA Westwood
For detailed technical eligibility, visit ClinicalTrials.gov.