TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

Completed · Phase 1/Phase 2

Conditions studied: HIV-1-infection

In brief

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test various doses of the combination of the antibodies for safety and pharmacokinetics in suppressed subjects on cART. Once dosing is established based on safety and PK, the optimally dosed combinations will be assessed as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 24 weeks.

Key facts

Study ID

NCT05275998

Run by

TaiMed Biologics Inc.

People needed

51

Starts

2022-07-05

Expected to finish

2024-11-20

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants having or meeting any of the following conditions or characteristics will be excluded from the study:
• Suppressed subjects who have not been on a stable DHHS recommended cART regimen for at least 3 months.
• Receipt of any monoclonal antibody for the treatment or prevention of HIV infection except for Sentinel subjects eligible for enrollment into Core groups.
• Suppressed subjects 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.
• 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 the first dose.
• 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 the first dose.
• Any chronic or acute medical condition, including chronic Hepatits B infection, chronic Hepatitis C infection with viremia, and 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, and fostemsavir. Note that a change in treatment regimen for intolerance does not meet criteria for virologic failure.

Where it is running

• Quest Clinical Research — San Francisco, California, United States
• CAN Community Health — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• North Texas Infectious Disease Consultants — Dallas, Texas, United States
• Crofoot Research Center, Inc. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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