Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant

AlloVir

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Respiratory Tract Viral Infections; Influenza Infection; Parainfluenza (PIV) Infection; Human Metapneumovirus (hMPV) Infection; Respiratory Syncytial Viral (RSV) Infection

Treatments: Biological: ALVR106; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04933968

P-106-001

Details and patient eligibility

About

A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).

Full description

The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo.

This trial will consist of two parts: Part A is Dose Escalation and Part B is Cohort Expansion.

Enrollment: 17 patients

Sex: All

Ages: 17 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
• Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
• Diagnosis of Upper or mild Lower Respiratory Tract Infection

Exclusion criteria

• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
• Infection by novel coronavirus disease 2019 (COVID-19)
• For HCT patients, evidence of Grade >2 GVHD; and for SOT patients, any history or evidence of GVHD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, visually identical to ALVR106

Treatment:

Biological: Placebo

ALVR106

Active Comparator group

Description:

ALVR106, visually identical to placebo

Treatment:

Biological: ALVR106