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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is a phase 1, open label study of the safety and antiretroviral activity of the 3BNC117-LS plus 10-1074-LS broadly neutralizing antibody (bNAb) combination plus N-803, an IL-15 superagonist complex, in ART-treated individuals living with HIV during interruption of ART. Thirty-six eligible participants will be enrolled sequentially and will be assigned to Group A or Group B after Monogram PhenoSense Assay results become available: Group A - participants with 3BNC117 and 10-1074 IC90 less or equal to 1 mcg/mL and MPI greater or equal to 98% by the Monogram PhenoSense assay using PBMCs; Group B - all other participants, including participants from whom the PhenoSense Assay (PBMC) does not yield a result. Participants will discontinue ART on day 2 (2 days after the first antibody infusions) and will be followed for up to 72 weeks while off ART and for 12 weeks after ART is resumed.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	3BNC117-LS	Intravenous infusion of 3BNC117-LS at 30 mg/kg
DRUG	10-1074-LS	Intravenous infusion of 10-1074-LS at 10 mg/kg
DRUG	N803	Subcutaneous injections of N803 at 6 mcg/kg

Timeline

• Start date: 2022-12-07
• Primary completion: 2025-12-09
• Completion: 2025-12-31
• First posted: 2022-02-17
• Last updated: 2026-03-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study