NCT07215468

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

A Phase 2b Study of the Safety, Pharmacokinetics, and Efficacy of the Combination of TMB-365 and TMB-380 as Maintenance Therapy in HIV-1 Infected Individuals Suppressed With Combination Antiretroviral Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: TaiMed Biologics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HIV -1 Infection

Interventions

Type	Name	Description
DRUG	TMB-365	A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
DRUG	TMB-380	A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
DRUG	Baseline ART	Baseline ART to be taken daily and orally

Timeline

• Start date: 2025-12-16
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-10-10
• Last updated: 2026-04-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study