NCT05890963

10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: David Ho · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for \> 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania. 20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order: * Arm 1 will receive standard daily oral ART. * Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV). * Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM). * Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV. * Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.

Detailed description

Although global initiatives have made great strides in controlling the human immunodeficiency virus (HIV) pandemic, HIV and acquired immune deficiency syndrome (AIDS) continue to impact the lives and livelihoods of a significant portion of the population. In 2019, 38 million individuals were living with HIV and 690,000 died of AIDS-related causes. Despite extensive global efforts for disease control over the last 20 years, 1.7 million individuals contract HIV annually. Antiretroviral therapy (ART) reduces morbidity and mortality associated with HIV by suppressing viral replication but does not eradicate infection. There are barriers to universal ART use that include toxicities, costs, drug resistance, and the need for lifelong adherence. To overcome these barriers, HIV broadly neutralizing antibodies (bNAbs) represent a novel approach to HIV prevention and treatment. The primary endpoint of change in viral load will be assessed at day 14. Participants will then transition to Step 2, during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	ART	ART is a combination of three or more drugs from different classes of antiretroviral medication.
DRUG	10E8.4/iMab	10E8.4/iMab is an engineered bispecific antibody with two arms combined into a single molecule that exhibits synergistic enhancement of antiviral activity. 10E8.4/iMab will be administered IV at the 600mg or 1800mg dose or IM at 600mg dose to participants in Step 1 per the Schedule of Events (SOE) based on the arm the participant is assigned.
DRUG	VRC07-523LS	VRC07-523LS is an engineered variant of VRC01, a bNAb that targets the CD4 binding site of the HIV-1 envelope. VRC07-523LS will be administered IV at the 1200mg dose to participants in Step 1 per the SOE.

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-04-01
• Completion: 2027-05-01
• First posted: 2023-06-06
• Last updated: 2025-04-25

Locations

1 site across 1 country: Tanzania

Regulatory

• FDA-regulated drug study