Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Trial ID or NCT#
Status
RECRUITING
Purpose
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.
Official Title
Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (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
Eligibility 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
- - 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Maninder Singh
+1 650-721-8389
View on ClinicalTrials.gov
