ALVR106 for Respiratory Viral Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Respiratory Viral Infection+9 MoreALVR106 - Biological
Eligibility
17 - 75
All Sexes
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Study Summary

This trial is testing a new cell therapy that targets four respiratory viruses in people who have had a hematopoietic cell transplant.

Eligible Conditions
  • Respiratory Viral Infection
  • Human Metapneumovirus Infection
  • Parainfluenza
  • Respiratory Infection
  • Respiratory Syncytial Virus (RSV)
  • Influenza
  • Parainfluenza Infection
  • Respiratory Syncytial Virus (RSV) Infection
  • Flu

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Up to Month 6

Day 10, Day 28
Progression form URTI to LRTI
Progression from URTI to LRTI
Day 28
Change in viral load (Part B)
Change in viral load measured by proportion of patients with >50% reduction in viral load in nasal swab
Identify the recommended Phase 2 (RP2D) (Part A)
Improvement in clinical signs and symptoms measured by patient and Investigator reported assessment of respiratory clinical symptoms
Day 365
Safety and Tolerability of ascending doses of ALVR106 (Part A) assessed through Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI)
Up to Day 365
Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests
Up to Month 6
Change in viral load

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

ALVR106
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

77 Total Participants · 2 Treatment Groups

Primary Treatment: ALVR106 · Has Placebo Group · Phase 1 & 2

ALVR106
Biological
ActiveComparator Group · 1 Intervention: ALVR106 · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 6

Who is running the clinical trial?

AlloVirLead Sponsor
11 Previous Clinical Trials
719 Total Patients Enrolled

Eligibility Criteria

Age 17 - 75 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
At least 1 target virus of interest detected.