MGD020 + MGD014 for HIV

No longer recruiting at 2 trial locations

Overseen By Global Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MacroGenics

Must be taking: Antiretrovirals

Must not be taking: HIV-1 entry inhibitors

Disqualifiers: HIV-1 vaccine, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two new treatments, MGD020 and MGD014, for individuals with HIV who are already on antiretroviral therapy (ART). The main goal is to assess the safety and effects of these treatments, both individually and combined, to determine if they can enhance the immune system's ability to fight HIV. The study consists of several parts, gradually increasing doses to identify the optimal level that participants can safely tolerate. The trial seeks individuals who have maintained HIV control with ART for at least two years and have a recent history of low viral load. As a Phase 1 trial, this research aims to understand how these new treatments work in people, offering participants the chance to be among the first to receive these innovative therapies.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current antiretroviral therapy (ART) medications. The trial requires participants to continue their ART throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MGD020 and MGD014 are new treatments being tested for safety in people with HIV who are already on antiretroviral therapy. Early studies suggest that starting with a low dose of MGD020 is safe because the specific cells it targets are uncommon in these individuals.

Lab studies have shown that MGD020 and MGD014 can effectively attach to the necessary cells, indicating their potential to work well together. However, as this is a phase 1 trial, the primary goal is to assess the safety of these treatments in humans. Researchers closely monitor for any side effects and evaluate how well participants tolerate the drugs. This information helps determine the best dose for future studies.

In summary, while early lab studies are promising, the current trial primarily focuses on confirming the safety of these treatments. Participants will be monitored closely to manage any side effects promptly. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MGD020 and MGD014 for HIV because they employ innovative mechanisms compared to traditional therapies. Unlike standard antiretroviral treatments that target the virus directly, MGD020 and MGD014 are designed to enhance the body's immune response against HIV. MGD020 is a bispecific molecule that engages T-cells to target HIV-infected cells, while MGD014 works as an immune checkpoint inhibitor to boost the immune system's ability to fight the virus. This novel approach has the potential to offer a more dynamic and possibly longer-lasting control of HIV.

What evidence suggests that MGD020 and MGD014 could be effective for HIV?

Research shows that MGD020 and MGD014 are designed to find and destroy cells infected with HIV. In this trial, some participants will receive MGD020 alone, which connects to CD3 and a part of the HIV-1 virus called gp41. Others will receive a combination of MGD020 and MGD014, with MGD014 connecting to CD3 and another part called gp120. These drugs help T cells, a type of white blood cell, attack the infected cells. Early lab studies indicate that MGD014 can effectively assist T cells in killing HIV-infected cells. Although these results are promising, they are based on lab studies, and more research is needed to understand how well these treatments work in people. ^{1 2 6 7 8}

Who Is on the Research Team?

Pepi Pencheva, MD

Principal Investigator

MacroGenics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test

I have been on HIV medication for at least 2 years and will continue it during the study.

Plasma HIV-1 RNA viral load: < 50 copies/mL at 2 time points within 24 months prior to screening (1 time point within 12 months prior to screening), < 50 copies/mL at screening, and not ≥ 50 copies/mL on 2 consecutive time points within 24 months nor > 1000 copies/mL at any time within 6 months prior to screening

Exclusion Criteria

I haven't had any HIV-1 vaccines or treatments in the last 6 months, except MGD014 or MGD020.

I haven't needed IV treatment for an infection in the last 7 days.

Participation in another investigational clinical research study within 60 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1A: Dose Escalation

Participants receive a single dose of MGD020 with a 2-week safety observation period before dose escalation

Up to 43 days

Multiple visits for dose administration and safety monitoring

Part 1B: Combination Dose Escalation

Participants receive a single dose of MGD020 and a fixed dose of MGD014, with dose escalation to determine MTD or MAD

Up to 43 days

Multiple visits for dose administration and safety monitoring

Part 2: Multi-dose Expansion

Participants receive the MTD or MAD of MGD020 and a fixed dose of MGD014 every 2 weeks for 3 doses over 4 weeks

4 weeks

3 visits for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MGD014
• MGD020

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2: MGD020 and MGD014 Experimental Treatment 2 Interventions

Multiple doses of MGD020 and MGD014

Group II: Part 1B: MTD/MAD MGD020 and MGD014 Experimental Treatment 2 Interventions

Single dose MGD020 and MGD014

Group III: Part 1B: MTD/MAD -1 MGD020 and MGD014 Experimental Treatment 2 Interventions

Single dose MGD020 and MGD014

Group IV: Part 1A: Dose level 6 Experimental Treatment 1 Intervention

Single dose MGD020

Group V: Part 1A: Dose level 5 Experimental Treatment 1 Intervention

Single dose MGD020

Group VI: Part 1A: Dose level 4 Experimental Treatment 1 Intervention

Single dose MGD020

Group VII: Part 1A: Dose level 3 Experimental Treatment 1 Intervention

Single dose MGD020

Group VIII: Part 1A: Dose level 2 Experimental Treatment 1 Intervention

Single dose MGD020

Group IX: Part 1A: Dose level 1 Experimental Treatment 1 Intervention

Single dose MGD020

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials

51

Recruited

5,400+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05261191

A Study of MGD020 Alone or Combined With MGD014 in ... Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9468498/

Bispecific antibody-derived molecules to target persistent ... A first-in-human phase 1 safety study of MGD020 in PLWH on ART will begin in 2022. This study will also evaluate the safety and PK of the MGD014 + MGD020 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07217379

NCT07217379 | The DART DELIVER-02 Study The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are ...

4. withpower.com withpower.com/trial/phase-1-acquired-immunodeficiency-syndrome-9-2025-58449

MGD020 + MGD014 for HIV (DELIVER-02 Trial) The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05261191/

Trial | NCT05261191 Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-mgd020-alone-or-combined-with-mgd014-in-persons-with-hiv-1-on-antiretroviral-therapy

A Study of MGD020 Alone or Combined With MGD014 in ... Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT05261191/Prot_000.pdf

NCT05261191 The 1 mcg/kg dose is expected to be a safe starting dose for MGD020 based on the rarity of target cells (HIV-1-infected, env-expressing cells) in PWH on ART, ...

8. trialx.com trialx.com/clinical-trials/listings/325232/the-dart-deliver-02-study/

The DART DELIVER-02 Study | Clinical Research Trial ... The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help ...