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NCT07215468 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HIV-1-infection, sponsored by TaiMed Biologics.

Recruiting
Registry status
Phase 2
Development phase
75
Enrollment target
11
Study locations

NCT07215468 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by TaiMed Biologics. The registered enrollment target is 75 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The trial reports 11 study locations across 5 states.

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The verdict

NCT07215468, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by TaiMed Biologics.

RECRUITING
Registry status
Phase 2
Development phase
75 participants
Enrollment target
11
Study locations

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

Conditions Studied

HIV-1-infection

Interventions

  • DRUG TMB-365
  • DRUG TMB-380
  • DRUG Baseline ART

Study Locations (11)

Florida

  • CAN Community Health Fort Lauderdale - Fort Lauderdale
  • Midway Immunology and Research Center (MIRC) - Ft. Pierce
  • CAN Community Health Miami Gardens - Miami Gardens
  • Midland Medical - Oakland Park
  • Orlando Immunology Center - Orlando
  • CAN Community Health Sarasota - Sarasota

California

  • Long Beach Education and Research Consultants - Long Beach
  • Quest Clinical Research - San Francisco

Georgia

  • Mercer University, Department of Internal Medicine, Clinical Research - Macon

Nevada

  • CAN Community Health Las Vegas - Las Vegas

Texas

  • The Crofoot Research Center, Inc. - Houston

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2025-12-16
Est. Completion 2027-08
Phase Phase 2

Sponsor

TaiMed Biologics

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07215468

The ClinicalTrials.gov registry entry for NCT07215468 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The listed sponsor is TaiMed Biologics, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 3 interventions - of which TMB-365 is the first listed.

NCT07215468 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT07215468 about?

NCT07215468 is a clinical study titled "HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study". 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 disconti...

What is the current status of trial NCT07215468?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2025-12-16. Estimated completion is 2027-08.

What conditions does trial NCT07215468 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT07215468?

The interventions under investigation include: TMB-365 (DRUG), TMB-380 (DRUG), Baseline ART (DRUG).

Who is sponsoring clinical trial NCT07215468?

This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07215468 being conducted?

This trial has 11 study locations across California, Florida, Georgia, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.