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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 below
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You are at least 1 year old.\n
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You cannot use umbilical cord blood as a source of stem cells.

Prevent Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 26 for reporting.

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 • NCT04693637
62%
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%
Decreased Appetite
19%
Back pain
19%
Platelet count decreased
19%
Fatigue
15%
Vomiting
15%
Oedema peripheral
15%
Pain
15%
Pyrexia
15%
Arthralgia
15%
Headache
15%
Dizziness
15%
Blood creatinine increased
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%
Presyncope
8%
Depression
8%
Hypertension
8%
Dry eye
8%
Abdominal Pain Lower
8%
Abdominal tenderness
8%
Catheter site pain
8%
Chronic graft versus host disease oral
8%
Alanine aminotransferase increased
8%
Pain in jaw
8%
Insomnia
8%
Acute Kidney injury
8%
Cough
8%
Epistaxis
8%
Pruritus
8%
Photophobia
8%
COVID-19
8%
Procedural Pain
8%
Chronic graft versus host disease in skin
8%
Upper Respiratory tract infection
8%
Skin Lesion
8%
Polyomavirus viraemia
8%
Transplant Failure
8%
Dry mouth
8%
Dehydration
8%
Musculoskeletal chest pain
8%
Erythema
8%
Muscular weakness
8%
Pollakiuria
4%
Chronic graft versus host disease in lung
4%
Suicidal Ideation
4%
Pneumonia
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%
Staphylococcal sepsis
4%
Decreased appetite
4%
Seizure
4%
Mental Disorder
4%
Nephrotic syndrome
4%
Genital herpes simplex
4%
Klebsiella bacteraemia
4%
Acute Myeloid Leukemia recurrent
4%
Cystitis haemorrhagic
4%
Post Transplant Lymphoproliferative disorder
4%
Acute Myeloid Leukaemia
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for adenovirus infections include antiviral agents and immune-based therapies. Posoleucel (ALVR105, Viralym-M) is an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets multiple viral pathogens, including adenovirus. This therapy works by introducing virus-specific T cells that can recognize and eliminate infected cells, thereby controlling the infection. Understanding these mechanisms is crucial for adenovirus infection patients because it highlights the potential for targeted immune responses to effectively manage and treat infections, especially in immunocompromised individuals who may not respond well to traditional antiviral medications.

Find a Location

Who is running the clinical trial?

AlloVirLead Sponsor
11 Previous Clinical Trials
375 Total Patients Enrolled
3 Trials studying Adenovirus Infections
83 Patients Enrolled for Adenovirus Infections

Media Library

Posoleucel (ALVR105,Viralym-M) (T cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05305040 — Phase 2 & 3
Adenovirus Infections Research Study Groups: Posoleucel (ALVR105), Placebo
Adenovirus Infections Clinical Trial 2023: Posoleucel (ALVR105,Viralym-M) Highlights & Side Effects. Trial Name: NCT05305040 — Phase 2 & 3
Posoleucel (ALVR105,Viralym-M) (T cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305040 — Phase 2 & 3
Adenovirus Infections Patient Testimony for trial: Trial Name: NCT05305040 — Phase 2 & 3
~142 spots leftby Jun 2025