HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study

NCT07215468 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TMB-b21
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

Brief Summary

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 48 weeks. Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression. Participants will:

1. 1.Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks
2. 2.Visit the clinic as schedule for checkups and tests

Conditions

HIV -1 Infection

Keywords

HIV-1 maintenance treatment; HIV switch therapy; Broadly neutralizing antibody (bNAb); HIV post-attachment inhibitor; monoclonal antibody (mAb)

Outcome Measures

Primary Outcomes (1)

• Antiviral activity of TMB-365 and TMB-380 as maintenance therapy compared to daily oral cART

  % of subjects with plasma HIV-1 RNA greater than or equal to 50 c/mL at week 48 by snapshot analysis as defined by US FDA

  Week 48

Secondary Outcomes (5)

• Number of participants who experience protocol-defined virologic failure

  48 weeks

• Pharmacokinetic profile of TMB-365

  Week 48

• Pharmacokinetic profile of TMB-380

  Week 48

• Safety of maintenance treatment regimen

  48 weeks

• Immune effects of maintenance therapy

  48 weeks

Study Arms (2)

Combination of TMB-365 and TMB-380 antibodies via IV infusions

EXPERIMENTAL

Participants will receive an IV infusion of the combination of TMB-365 and TMB-380 each every 8 weeks.

Drug: TMB-365; Drug: TMB-380

Baseline oral cART

ACTIVE COMPARATOR

Participants will continue suppressive daily oral cART

Drug: Baseline ART

Interventions

TMB-365 DRUG

A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously

Combination of TMB-365 and TMB-380 antibodies via IV infusions

TMB-380 DRUG

A broadly neutralizing antibody (bNAb) against HIV to be given intravenously

Also known as: VRC07-523LS

Combination of TMB-365 and TMB-380 antibodies via IV infusions

Baseline ART DRUG

Baseline ART to be taken daily and orally

Baseline oral cART

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age on the day of Screening.
• Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Geenius™ or a second antibody test by a method other than the initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral load at or prior to screening.
• On continuous suppressive cART for at least 6 months prior to Screening with one documented HIV-1 RNA level \<50 copies/mL within 6 months of Screening. Continuous cART is defined as no interruptions greater than 3 consecutive days. cART is defined as a DHHS recommended regimen. Study participants should be on a stable oral regimen for at least 3 months prior to Screening.
• Screening plasma HIV-1 RNA \< 50 copies/mL
• CD4+ T cell count \>350 cells/mm3
• Laboratory values obtained within 35 days prior to the first dose:
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 100,000/mm3
• Absolute neutrophil count ≥ 1,000/mm3
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x upper limit of normal (ULN)
• Creatinine clearance (CrCl) of ≥ 50 mL/min
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
• In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.
• Persons of childbearing potential sexually active with a partner who can impregnate them, must agree to use one effective method of contraception from the time of signing the consent to completion of the study, and agree to pregnancy testing as per the Schedule of Events and Procedures. Persons of childbearing potential are participants born female who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least one year without menses), and are not otherwise sterile by medical evaluation.

You may not qualify if:

• Receipt of any monoclonal antibody for the treatment or prevention of HIV infection.
• Receiving cabotegravir and rilpivirine intramuscularly as maintenance therapy for HIV-1 infection.
• Pregnant, planning a pregnancy during the trial period, or lactating.
• Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to a MAb.
• History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy for other conditions such as COVID.
• Major psychiatric illness including any history of schizophrenia or severe psychosis, uncontrolled bipolar disorder requiring acute therapy, or suicide attempt in the previous three years.
• Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to Baseline.
• Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine, high dose systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 180 days prior to Baseline.
• Any chronic or acute medical condition, including chronic Hepatitis B infection, chronic Hepatitis C infection with viremia, drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug.
• Lack of adequate venous access.
• Individuals who have experienced virologic failure during treatment with two or more cART treatment regimens and those being treated with regimens containing either ibalizumab, enfuvirtide, maraviroc, or fostemsavir. Note that a change in treatment regimen for intolerance does not meet criteria for treatment failure.

Sponsors & Collaborators

• TaiMed Biologics Inc.: lead

Study Sites (10)

Quest Clinical Research

San Francisco, California, 94115, United States

RECRUITING

CAN Community Health Fort Lauderdale

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Midway Immunology and Research Center (MIRC)

Ft. Pierce, Florida, 34982, United States

RECRUITING

CAN Community Health Miami Gardens

Miami Gardens, Florida, 33055, United States

RECRUITING

Midland Medical

Oakland Park, Florida, 33334, United States

RECRUITING

Orlando Immunology Center

Orlando, Florida, 32803, United States

RECRUITING

CAN Community Health Sarasota

Sarasota, Florida, 34237, United States

RECRUITING

CAN Community Health Las Vegas

Las Vegas, Nevada, 89104, United States

RECRUITING

The Rockefeller University

New York, New York, 10065, United States

RECRUITING

The Crofoot Research Center, Inc.

Houston, Texas, 77098, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 10, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)