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

Summary

This trial is testing posoleucel, a treatment made from special immune cells, in high-risk patients who have had a stem cell transplant. The goal is to help their immune systems fight off six specific viruses and prevent infections.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14

Secondary study objectives

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%

Dyspnoea

23%

Abdominal Pain

23%

Tremor

23%

Pain in extremity

19%

Platelet count decreased

19%

Nausea

19%

Anaemia

19%

Fatigue

19%

Constipation

19%

Chills

19%

Decreased Appetite

19%

Back pain

15%

Vomiting

15%

Dizziness

15%

Blood creatinine increased

15%

Oedema peripheral

15%

Pain

15%

Pyrexia

15%

Headache

15%

Arthralgia

12%

Cytomegalovirus viraemia

12%

Aspartate aminotransferase increased

12%

Sepsis

12%

Cytomegalovirus infection reactivation

12%

Urinary Tract infection

12%

White blood cell count decreased

12%

Hyperglycaemia

12%

Graft versus host disease in gastrointestinal tract

12%

Myalgia

12%

Rash

12%

Hypotension

Alanine aminotransferase increased

Dehydration

Procedural Pain

Chronic graft versus host disease in skin

COVID-19

Upper Respiratory tract infection

Transplant Failure

Abdominal tenderness

Dry mouth

Abdominal Pain Lower

Catheter site pain

Pain in jaw

Epistaxis

Chronic graft versus host disease oral

Polyomavirus viraemia

Muscular weakness

Musculoskeletal chest pain

Acute Kidney injury

Erythema

Pruritus

Presyncope

Pollakiuria

Cough

Depression

Insomnia

Skin Lesion

Photophobia

Hypertension

Dry eye

Pancreatitis Necrotising

COVID 19

Genital herpes simplex

Post Transplant Lymphoproliferative disorder

Pancreatitis Acute

Bacteraemia

Mental Disorder

Hypersensitivity

Adrenoleukodystrophy

Suicidal Ideation

Chronic graft versus host disease in lung

Clostridium difficile colitis

Pneumonia

Staphylococcal sepsis

Nephrotic syndrome

Adenovirus infection

Enterocolitis bacterial

Gastroenteritis

Klebsiella bacteraemia

Cystitis haemorrhagic

Decreased appetite

Acute Myeloid Leukaemia

Acute Myeloid Leukemia recurrent

Seizure

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.