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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
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

Study Summary

This trial is studying MGD020 as a possible treatment for HIV-1. MGD020 is a molecule that binds to CD3 and gp41 subunit of HIV-1 envelope. This study will test the safety, tolerability, and how well MGD020 works in people with HIV-1 on antiretroviral therapy. The study has 3 parts. Part 1 will test different doses of MGD020 given as a single dose. Part 2 will test MGD020 in combination with MGD014, given as a single dose. Part 3 will test MGD020 and MGD014 given as 3 doses over 4 weeks.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AUC of MGD014
Anti-drug antibody formation to MGD014
Anti-drug antibody formation to MGD020
+14 more

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
MGD014
2018
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,325 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,895 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,230 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
~20 spots leftby May 2025
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