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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.
Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 26
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
Select...
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 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
Secondary outcome measures
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus
Side effects data
From 2023 Phase 2 & 3 trial • 26 Patients • NCT0469363762%
Diarrhoea
38%
Acute graft versus host disease in skin
23%
Weight decreased
23%
Abdominal Pain
23%
Tremor
23%
Pain in extremity
23%
Dyspnoea
19%
Anaemia
19%
Chills
19%
Constipation
19%
Nausea
19%
Fatigue
19%
Platelet count decreased
19%
Decreased Appetite
19%
Back pain
15%
Blood creatinine increased
15%
Vomiting
15%
Oedema peripheral
15%
Pain
15%
Pyrexia
15%
Arthralgia
15%
Headache
15%
Dizziness
12%
Cytomegalovirus viraemia
12%
Sepsis
12%
White blood cell count decreased
12%
Hyperglycaemia
12%
Urinary Tract infection
12%
Aspartate aminotransferase increased
12%
Myalgia
12%
Rash
12%
Graft versus host disease in gastrointestinal tract
12%
Hypotension
12%
Cytomegalovirus infection reactivation
8%
Erythema
8%
Procedural Pain
8%
Presyncope
8%
Depression
8%
Dehydration
8%
Hypertension
8%
Dry eye
8%
Abdominal Pain Lower
8%
Abdominal tenderness
8%
Dry mouth
8%
Catheter site pain
8%
Chronic graft versus host disease oral
8%
COVID-19
8%
Alanine aminotransferase increased
8%
Musculoskeletal chest pain
8%
Pain in jaw
8%
Insomnia
8%
Acute Kidney injury
8%
Cough
8%
Epistaxis
8%
Pruritus
8%
Photophobia
8%
Chronic graft versus host disease in skin
8%
Upper Respiratory tract infection
8%
Skin Lesion
8%
Polyomavirus viraemia
8%
Transplant Failure
8%
Muscular weakness
8%
Pollakiuria
4%
Pneumonia
4%
Suicidal Ideation
4%
Pancreatitis Acute
4%
Adrenoleukodystrophy
4%
Pancreatitis Necrotising
4%
Hypersensitivity
4%
Adenovirus infection
4%
Bacteraemia
4%
Clostridium difficile colitis
4%
COVID 19
4%
Enterocolitis bacterial
4%
Gastroenteritis
4%
Genital herpes simplex
4%
Klebsiella bacteraemia
4%
Staphylococcal sepsis
4%
Decreased appetite
4%
Seizure
4%
Mental Disorder
4%
Nephrotic syndrome
4%
Acute Myeloid Leukemia recurrent
4%
Chronic graft versus host disease in lung
4%
Acute Myeloid Leukaemia
4%
Cystitis haemorrhagic
4%
Post Transplant Lymphoproliferative disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posoleucel (ALVR105)
Prevent Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Posoleucel (ALVR105)Experimental Treatment1 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posoleucel (ALVR105)
2021
Completed Phase 3
~30
Find a Location
Who is running the clinical trial?
AlloVirLead Sponsor
11 Previous Clinical Trials
374 Total Patients Enrolled
3 Trials studying Adenovirus Infections
83 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 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.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
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