Study Summary
This trial will test an allogeneic, multi-virus specific T cell therapy for six viral pathogens.
Eligible Conditions
- Epstein-Barr Virus (EBV) Infection
- Adenovirus Infections
- BK Virus Infection
- Cytomegalovirus (CMV)
- Human Herpes Virus 6 (HHV-6) Infection
- Progressive Multifocal Leukoencephalopathy (PML)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 5 Secondary · Reporting Duration: Through Week 14 and 26
Week 14
Mean area under the curve (AUC) viral load
Number of clinically significant infections or episodes of end-organ disease due to each virus
Through Week 26
Incidence of Adverse Events
Number of clinically significant infections or episodes of end-organ disease
Overall and Non-Relapse Mortality
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Posoleucel (ALVR105)
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
302 Total Participants · 2 Treatment Groups
Primary Treatment: Posoleucel (ALVR105) · Has Placebo Group · Phase 2 & 3
Posoleucel (ALVR105)
Biological
ActiveComparator Group · 1 Intervention: Posoleucel (ALVR105) · Intervention Types: BiologicalPlacebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through week 14 and 26
Who is running the clinical trial?
AlloVirLead Sponsor
11 Previous Clinical Trials
494 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You received a stem cell transplant from a donor who is not related to you.
You cannot participate if your stem cells will be obtained from umbilical cord blood.
The donor for the transplant is only a half-match to you.
Who else is applying?
What state do they live in?
| Florida | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I have been dealing with CFS for 3 years now. Age 80. Never been a drinker or smoker. CFS seems to be getting worse. Huge CRP labs. Tested positive for EBV in 3 different simultaneous tests. Chemical engineer. Widowed."
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Tzannou, Ifigeneia, Anastasia Papadopoulou, Swati Naik, Kathryn Leung, Caridad A. Martinez, Carlos A. Ramos, George Carrum, et al.. 2017. “Off-the-shelf Virus-specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-cell Transplantation”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.73.0655.
- Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.
- 2022. "Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05305040.
Frequently Asked Questions
Could you estimate how many hospitals are running this trial?
"To make enrolling easier for patients, this trial is being run out of 50 locations. 3 of these sites are in Richmond, Nashville and Toronto with the other 47 located elsewhere." - Anonymous Online Contributor
Unverified Answer
Are people still being sought out for this research project?
"This study, which can be found on clinicaltrials.gov, is looking for participants. The trial was first posted on March 21st, 2022 and was last edited on November 8th, 2022." - Anonymous Online Contributor
Unverified Answer