MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

NCT03570918 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: CP-MGD014-01272201500032C-2-0-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV-1-infection

Keywords

HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emerging Adverse Events

  Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

  up to 77 days

Secondary Outcomes (9)

• AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014

  Study Day 0 to 42

• Cmax: Maximum Plasma Concentration

  Study Day 0

• Tmax: Time to Maximum Concentration

  Study Day 0

• Ctrough: Trough Level Concentration

  Study Day 14

• Clearance

  Study Day 0 to 42

Study Arms (9)

MGD014 0.1 micrograms/kilogram (mcg/kg)

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 0.3 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 1.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 3.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 10.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 30.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 100.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 300.0 mcg/kg

EXPERIMENTAL

a single 2-hour infusion

Biological: MGD014

MGD014 300.0 mcg/kg multiple doses

EXPERIMENTAL

2-hour infusion every 2 weeks for 3 infusions

Biological: MGD014

Interventions

MGD014 BIOLOGICAL

HIV-1 x CD3 bispecific DART molecule

MGD014 0.1 micrograms/kilogram (mcg/kg); MGD014 0.3 mcg/kg; MGD014 1.0 mcg/kg; MGD014 10.0 mcg/kg; MGD014 100.0 mcg/kg; MGD014 3.0 mcg/kg; MGD014 30.0 mcg/kg; MGD014 300.0 mcg/kg; MGD014 300.0 mcg/kg multiple doses

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness of participant to provide written informed consent.
• HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
• On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.
• Plasma HIV-1 RNA \< 50 copies/mL at two time points in the previous 12 months prior to screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive time points in the last 24 months.
• Adequate organ function based on acceptable laboratory parameters.

You may not qualify if:

• Women of childbearing potential defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or menopause.
• History or other evidence of severe illness, immunodeficiency other than HIV, or any other condition that would make the potential participant unsuitable for study.
• History or other evidence of any condition or process for which signs or symptoms could be confused with reactions to MGD014.
• History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months prior to screening.
• History of clinically significant cardiovascular disease, severe allergic reactions, malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2 years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding disorder.
• Evidence of active viral, or antifungal treatment within 7 days prior to the initiation of study drug
• Active, asymptomatic, or suspected COVID-19/SARS-CoV-2 infection.
• Active, untreated syphilis.
• Use of blood products, cytokine therapy, growth-stimulating factors, cytotoxic chemotherapy or investigational therapy within 90 days.
• Current use of the antivirals maraviroc and/or enfuvirtide.
• Any vaccination with exception of flu vaccine within 30 days of screening.

Sponsors & Collaborators

• MacroGenics: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MacroGenics, Inc.

info@Macrogenics.com

301-251-5172

Study Officials

• Chief Medical Officer

  MacroGenics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label dose-escalation study

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: September 25, 2018
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: September 2, 2022
• Results First Posted: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)