Education and Training
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
This is a Phase 3 study to evaluate posoleucel (ALVR105, 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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Posoleucel (ALVR105)
- biological: Placebo
Eligibility
Key Inclusion Criteria:
- Any age at the day of screening visit.
- No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6,
and/or JCV
- Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical
engraftment at time of dosing
- 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
- Matched or Mismatched unrelated donor
- Use of umbilical cord blood as stem cell source
- Ex vivo graft manipulation resulting in T cell depletion
- Received anti-thymocyte globulin or alemtuzumab (Campath-1H)
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 Grade ≥3 CRS requiring treatment
associated with the administration of peptides, proteins, and/or antibodies
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent
dose >1.0 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.
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maninder Singh
+1 650-721-8389
I'm interested