CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
TMB-365/TMB-380drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05275998
NCT05275998Phase 2Completed
CompareCT.gov

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

TaiMed Biologics Inc.·interventional·Posted Mar 11, 2022·Updated Oct 22, 2025

In Brief

A Phase 2 clinical trial evaluating TMB-365/TMB-380 for HIV-1-infection. Completed, enrolled 51 participants across 6 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 11, 2022
Enrollment StartJul 5, 2022
Primary CompletionNov 20, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.3 years ago

Interventions

TMB-365/TMB-380drug

Monoclonal antibodies to be given intravenously