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Clinical Trial 21426

Cancer Type: Malignant Hematology
Study Type: Prevention
NCT#: NCT05305040

Phase: Phase I/II
Principal Investigator: Faramand, Rawan

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Overview

Study Title

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

Summary

This is a Phase 3 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.

Objective

Treatments

Therapies

Therapy (NOS)

Medications

Inclusion Criteria

Key Inclusion Criteria:

  • No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
  • 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
  • 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)
  • Other criteria may apply

  • Exclusion Criteria

    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
  • Other criteria may apply

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