3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) - Trial NCT05245292
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.
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Study Focus
Sponsor & Location
Rockefeller University
Timeline & Enrollment
Phase 1
Nov 18, 2022
Dec 01, 2025
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
Data Source
ClinicalTrials.gov
NCT05245292
Non-Device Trial