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Bispecific DART molecule

MGD020 + MGD014 for HIV

Phase 1
Waitlist Available
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On continuous antiretroviral therapy (ART) for at least 24 months prior to screening and must continue ART throughout the study
Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent
Must not have
Active viral, bacterial, or systemic fungal infection requiring intravenous antibiotic, antiviral, or antifungal treatment within 7 days prior to the initiation of study drug
History of virologic failure on an ART regimen containing FDA-approved HIV-1 entry inhibitors (maraviroc, enfuvirtide, and/or ibalizumab). Virologic failure is defined as a confirmed plasma HIV-1 RNA ≥ 150 copies/mL following assessment of drug adherence, repeat HIV-1 RNA testing with continued treatment, and/or resistance testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2
Awards & highlights
No Placebo-Only Group

Summary

This trial tests two new drugs, MGD020 and MGD014, in people with HIV who are already on treatment. These drugs help the immune system find and kill HIV-infected cells by acting as a bridge between immune cells and the virus.

Who is the study for?
This trial is for adults aged 18-70 with well-controlled HIV on antiretroviral therapy (ART) for at least 24 months, having a viral load under 50 copies/mL. They must have stable health, no recent serious infections or COVID-19, and not be in other studies. Participants should agree to contraception use during the study and for four months after.
What is being tested?
The trial tests MGD020 alone or combined with MGD014 in people with HIV. It's an early-phase study assessing safety, tolerability, how the body processes these drugs (pharmacokinetics), immune response (immunogenicity), and drug effects (pharmacodynamics). The treatment involves different doses of MGD020 followed by combination doses with MGD014.
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to immune-based therapies such as infusion-related symptoms, changes in blood counts or organ function due to redirected T cell activity against infected cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on HIV medication for at least 2 years and will continue it during the study.
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I am between 18 and 70 years old and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't needed IV treatment for an infection in the last 7 days.
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I have HIV and my previous treatment with specific HIV medications was not successful.
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I currently have COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Therapeutic procedure
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation in participants receiving MGD020 and MGD014 in Part 2.
Secondary study objectives
AUC of MGD014
Anti-drug antibody formation to MGD014
Anti-drug antibody formation to MGD020
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Part 2: MGD020 and MGD014Experimental Treatment2 Interventions
Multiple doses of MGD020 and MGD014
Group II: Part 1B: MTD/MAD MGD020 and MGD014Experimental Treatment2 Interventions
Single dose MGD020 and MGD014
Group III: Part 1B: MTD/MAD -1 MGD020 and MGD014Experimental Treatment2 Interventions
Single dose MGD020 and MGD014
Group IV: Part 1A: Dose level 6Experimental Treatment1 Intervention
Single dose MGD020
Group V: Part 1A: Dose level 5Experimental Treatment1 Intervention
Single dose MGD020
Group VI: Part 1A: Dose level 4Experimental Treatment1 Intervention
Single dose MGD020
Group VII: Part 1A: Dose level 3Experimental Treatment1 Intervention
Single dose MGD020
Group VIII: Part 1A: Dose level 2Experimental Treatment1 Intervention
Single dose MGD020
Group IX: Part 1A: Dose level 1Experimental Treatment1 Intervention
Single dose MGD020
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MGD020
2022
Completed Phase 1
~30
MGD014
2022
Completed Phase 1
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for HIV include antiretroviral therapies (ART) that target various stages of the HIV life cycle to prevent the virus from replicating. MGD020 and MGD014 are bispecific DART® molecules that redirect CD3+ T lymphocytes to kill HIV-1-infected CD4+ T cells by targeting the gp41 and gp120 subunits of the HIV-1 envelope, respectively. This mechanism is crucial as it directly enhances the immune system's ability to eliminate infected cells, potentially reducing the viral reservoir and improving long-term outcomes for patients. Other ARTs, such as integrase inhibitors (e.g., bictegravir) and reverse transcriptase inhibitors (e.g., emtricitabine and tenofovir alafenamide), work by inhibiting viral enzymes necessary for HIV replication. These treatments are essential for maintaining viral suppression, preventing disease progression, and reducing the risk of transmission.
Interaction of C-terminal sequences of human immunodeficiency virus reverse transcriptase with template primer.Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,108 Total Patients Enrolled
Department of Health and Human ServicesFED
232 Previous Clinical Trials
935,679 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,818 Previous Clinical Trials
8,161,671 Total Patients Enrolled

Media Library

MGD014 (Bispecific DART molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05261191 — Phase 1
HIV Research Study Groups: Part 1A: Dose level 2, Part 2: MGD020 and MGD014, Part 1B: MTD/MAD -1 MGD020 and MGD014, Part 1A: Dose level 3, Part 1A: Dose level 1, Part 1A: Dose level 5, Part 1A: Dose level 6, Part 1A: Dose level 4, Part 1B: MTD/MAD MGD020 and MGD014
HIV Clinical Trial 2023: MGD014 Highlights & Side Effects. Trial Name: NCT05261191 — Phase 1
MGD014 (Bispecific DART molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261191 — Phase 1
~8 spots leftby Dec 2025