Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
a study on Adenovirus BK Virus Cytomegalovirus Epstein Barr Virus Human Herpesvirus 6 JC Virus Allogeneic Hematopoietic Cell Transplantation Hematopoietic Cell Transplantation
Summary
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
Summary
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
Details
This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.
There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.
Keywords
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection, Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M, Virus-specific T cells (VSTs), Cytotoxic T Lymphocytes (CTLs), Infections, Communicable Diseases, Virus Diseases, Adenoviridae Infections, Posoleucel (ALVR105)
Eligibility
You can join if…
- 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 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)
You CAN'T join if...
- 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 >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.
Locations
- University of California, Los Angeles (UCLA)
accepting new patients
Los Angeles California 90095 United States - City of Hope
accepting new patients
Duarte California 91010 United States - Stanford University
accepting new patients
Palo Alto California 94306 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AlloVir
- ID
- NCT05305040
- Phase
- Phase 2/3 research study
- Study Type
- Interventional
- Participants
- Expecting 302 study participants
- Last Updated