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T cell Therapy
Posoleucel for Multi-Virus Infection Prevention Post-Transplant (Prevent Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by AlloVir
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥1 year of age at the day of screening visit.
Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 14 and 25
Awards & highlights
Prevent Trial Summary
This trial will test an allogeneic, multi-virus specific T cell therapy for six viral pathogens.
Who is the study for?
This trial is for patients who've had a stem cell transplant from a donor to treat blood or bone marrow conditions. They should be at least 1 year old, have received the transplant within the last 15-42 days, and not have active severe infections or graft-versus-host disease. Patients with recent serious viral diseases or high-dose steroid treatment are excluded.Check my eligibility
What is being tested?
The study tests Posoleucel (ALVR105), designed to prevent six different viral infections in patients after an allogeneic hematopoietic cell transplant. Participants will either receive this multi-virus specific T cell therapy or a placebo to compare effectiveness.See study design
What are the potential side effects?
Possible side effects of Posoleucel include reactions related to immune activation such as fever and fatigue, potential worsening of existing infections, and infusion-related reactions. The severity can range from mild symptoms to more significant issues requiring treatment.
Prevent Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are at least 1 year old.\n
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You have recently received a bone marrow transplant from a donor and have shown signs of successful engraftment.
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You received stem cells from a half-matched relative, a matched or unmatched unrelated donor, or umbilical cord blood.
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You received a stem cell transplant from a donor who is not related to you.
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You cannot participate if your stem cells will be obtained from umbilical cord blood.
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If you have received a bone marrow transplant from someone else, you must have shown signs of successful recovery within 15 to 42 days after the transplant.
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You cannot use umbilical cord blood as a source of stem cells.
Prevent Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through week 14 and 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 14 and 25
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Incidence of Adverse Events
Number of clinically significant infections or episodes of end-organ disease
Number of clinically significant infections or episodes of end-organ disease due to each virus
+1 morePrevent Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Posoleucel (ALVR105)Active Control1 Intervention
Administered as 2-4 milliliter infusion, visually identical to placebo
Group II: PlaceboPlacebo Group1 Intervention
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Find a Location
Who is running the clinical trial?
AlloVirLead Sponsor
11 Previous Clinical Trials
377 Total Patients Enrolled
3 Trials studying Adenovirus Infections
86 Patients Enrolled for Adenovirus Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at least 1 year old.\nYou received stem cells from a half-matched relative, a matched or unmatched unrelated donor, or umbilical cord blood.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.You have had a recurrence of a previous cancer, except if it's only a small amount of remaining cancer cells.If you have received a bone marrow transplant from someone else, you must have shown signs of successful recovery within 15 to 42 days after the transplant.You cannot use umbilical cord blood as a source of stem cells.The donor for the transplant is only a half-match to you.You have recently received a bone marrow transplant from a donor and have shown signs of successful engraftment.You have experienced severe side effects in the past from certain medications that caused a condition called cytokine release syndrome (CRS).You have a donor who is a close family member, like a parent or sibling, and shares some of your genetic characteristics.
Research Study Groups:
This trial has the following groups:- Group 1: Posoleucel (ALVR105)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Adenovirus Infections Patient Testimony for trial: Trial Name: NCT05305040 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Pennsylvania
Maryland
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
1
What site did they apply to?
Stanford University
University of California, San Francisco Medical Center
Fred Hutchinson Cancer Research Center
Other
Why did patients apply to this trial?
Cure for HSV-2. 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.
PatientReceived no prior treatments
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