NCT03570918

MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label single-center study to determine the safety of MGD014 in participants with human immunodeficiency virus (HIV) infection on stable suppressive antiretroviral therapy (ART).

Detailed description

Eligible participants will be maintained on ART and receive either one infusion (Part 1) or multiple infusions of MGD014 (Part 2). Part 1 is a single ascending dose study with a 1+3 design for the first 2 dose cohorts, and a 3+3 design with staggered accrual for the 6 higher dose cohorts, with an aim of determining the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending doses up to either the Optimal Biologic Dose (OBD) or the maximum administered dose (MAD). Part 2 is a multi-dose expansion cohort with MGD014 administered at the OBD, as determined in Part 1. In Part 2, additional assessments on the effects of MGD014 on HIV latent infection parameters will be evaluated.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	MGD014	HIV-1 x CD3 bispecific DART molecule

Timeline

• Start date: 2018-09-25
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2018-06-27
• Last updated: 2022-09-02
• Results posted: 2022-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study