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NCT05245292

3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)

An Open Label, Single Arm Study of the Safety and Antiretroviral Activity of Two Long-acting Broadly Neutralizing Antibodies Plus an IL-15 Superagonist in ART-treated Adults Living With HIV During Analytical Treatment Interruption
Rockefeller University·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Human Immunodeficiency Virus
Drug/Device/Intervention
3BNC117-LS
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Rockefeller University
Location
New York,New York,Philadelphia, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 18, 2022
End date
Dec 01, 2025
Enrollment
36 participants
Primary outcome

Treatment-related Grade 3 adverse events and serious adverse events,Any serious adverse events,Dosing completion,Viral rebound before or at week 24 post withdrawing ART,ART not restarted by weeks 60 and 72,ART not restarted when bNABs below threshold

Summary

The proposed study is a phase 1, open label, single arm study to evaluate the safety and
 antiretroviral activity of the combination of two long-acting broadly neutralizing
 antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, both
 intravenously (IV) at week 0, plus an IL-15 superagonist complex, N-803, dosed at 6 mcg/kg,
 subcutaneously (SC) at week 1 and then every 3 weeks for a total of 8 doses, in ART-treated
 adults living with HIV during analytical treatment interruption.

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesAsymptomatic human immunodeficiency virus [HIV] infection status
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05245292
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05245292 through Pure Global AI's free database. This Phase 1 trial is sponsored by Rockefeller University and is currently Recruiting. The study focuses on Human Immunodeficiency Virus. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.