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

NCT05245292 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Weill Medical College of Cornell University

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Marina Caskey, MD · The Rockefeller University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2025-12-09
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245292 on ClinicalTrials.gov