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Monoclonal Antibodies

Sotrovimab for Blood Cancers

Phase 1
Waitlist Available
Led By Alpana Waghmare
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12, 16, 20 and 24 weeks (and week 40 if positive at week 24)
Awards & highlights

Study Summary

This phase I trial studies the process by which sotrovimab is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics) in hematopoietic stem cell transplant recipients. Sotrovimab is a monoclonal antibody that may target and bind to a specific protein on SARS-CoV-2 and block its viral attachment and entry into human cells. This may slow the progression of the disease and accelerate recovery, and may potentially provide temporary protection against infection with SARS-CoV-2 in hematopoietic stem cell transplant recipients.

Eligible Conditions
  • Cancer
  • Blood Cancers
  • Coronavirus Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12, 16, 20 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12, 16, 20 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Half-life of sotrovimab (VIR-7831) post-transplant
Neutralizing antibody titers
Secondary outcome measures
Anti-drug antibody levels from serum/plasma
Antibody levels from serum/plasma
Frequency of breakthrough SARS-CoV-2 acquisition
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (Sotrovimab)Experimental Treatment3 Interventions
Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1890
Sotrovimab
2022
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,225 Total Patients Enrolled
Vir Biotechnology, Inc.Industry Sponsor
27 Previous Clinical Trials
13,238 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,196 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
2022. "Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05135650.
~6 spots leftby Apr 2025
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