What side effects are associated with this type of intervention?

Common side effects of multi-virus specific T cell therapies, such as Posoleucel (ALVR105, Viralym-M), include infusion-related reactions like fever, chills, and fatigue. There is also a risk of cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing. Additionally, immune effector cell-associated neurotoxicity syndrome (ICANS) may occur, leading to confusion, seizures, and other neurological symptoms. Careful monitoring and management of these side effects are essential for safe treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for adenovirus infections that are similar to Posoleucel (ALVR105, Viralym-M), which is an allogeneic, off-the-shelf multi-virus specific T cell therapy. Posoleucel targets multiple viruses including BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. While there are antiviral drugs approved for some of these viruses, such as ganciclovir for cytomegalovirus, there are no multi-virus specific T cell therapies currently approved by the FDA for adenovirus or the other viruses targeted by Posoleucel.

What other types of research exist?

Promising alternatives to Posoleucel for adenovirus infections in 2024 may include other multi-virus specific T cell therapies or novel antiviral agents currently under investigation. Consulting with a healthcare provider for the latest clinical trials and approved treatments is recommended.

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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

Must not have

Evidence of active Grade >2 acute GVHD

Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through week 26

Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have experienced severe side effects in the past from certain medications that caused a condition called cytokine release syndrome (CRS).

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You have had a recurrence of a previous cancer, except if it's only a small amount of remaining cancer cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through week 26

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%

Abdominal Pain

23%

Weight decreased

23%

Tremor

23%

Pain in extremity

23%

Dyspnoea

19%

Chills

19%

Anaemia

19%

Constipation

19%

Nausea

19%

Decreased Appetite

19%

Back pain

19%

Platelet count decreased

19%

Fatigue

15%

Blood creatinine increased

15%

Vomiting

15%

Oedema peripheral

15%

Pyrexia

15%

Headache

15%

Pain

15%

Dizziness

15%

Arthralgia

12%

Cytomegalovirus viraemia

12%

White blood cell count decreased

12%

Graft versus host disease in gastrointestinal tract

12%

Sepsis

12%

Aspartate aminotransferase increased

12%

Rash

12%

Urinary Tract infection

12%

Hyperglycaemia

12%

Myalgia

12%

Hypotension

12%

Cytomegalovirus infection reactivation

Hypertension

Presyncope

Depression

Polyomavirus viraemia

Dry eye

Abdominal Pain Lower

Abdominal tenderness

Catheter site pain

Alanine aminotransferase increased

Pain in jaw

Insomnia

Pruritus

COVID-19

Procedural Pain

Cough

Photophobia

Chronic graft versus host disease in skin

Skin Lesion

Chronic graft versus host disease oral

Upper Respiratory tract infection

Transplant Failure

Acute Kidney injury

Dry mouth

Dehydration

Musculoskeletal chest pain

Erythema

Muscular weakness

Pollakiuria

Epistaxis

Pneumonia

Pancreatitis Necrotising

Klebsiella bacteraemia

Hypersensitivity

Genital herpes simplex

Pancreatitis Acute

Adrenoleukodystrophy

Adenovirus infection

Bacteraemia

Clostridium difficile colitis

COVID 19

Enterocolitis bacterial

Gastroenteritis

Staphylococcal sepsis

Decreased appetite

Mental Disorder

Nephrotic syndrome

Suicidal Ideation

Seizure

Acute Myeloid Leukemia recurrent

Cystitis haemorrhagic

Post Transplant Lymphoproliferative disorder

Acute Myeloid Leukaemia

Chronic graft versus host disease in lung

100%

80%

60%

40%

20%

Study treatment Arm

Posoleucel (ALVR105)

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

0 / 11Eligibility criteria met

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.