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
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