---
title: "Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial"
id: "nature-0-bispecific-10e8-4-imab-broadly-neutralizing-antibody-in-people-with-or-without"
canonical_url: "https://medichelpline.com/clinical-feed/nature-0-bispecific-10e8-4-imab-broadly-neutralizing-antibody-in-people-with-or-without"
content_type: "clinical_feed_article"
specialty: "Research Highlights"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04472-w"
published_at: "2026-07-07T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-0-bispecific-10e8-4-imab-broadly-neutralizing-antibody-in-people-with-or-without
- **Specialty:** [Research Highlights](https://medichelpline.com/clinical-feed/research-highlights.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04472-w)
- **Published At:** 2026-07-07T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
Broadly neutralizing antibodies (bnAbs) are a promising tool for HIV prevention and treatment. Here we conducted a first-in-human, phase 1 trial of the bispecific 10E8.4/iMab antibody, which consists of a 10E8.4 arm binding the HIV-1 envelope glycoprotein membrane-proximal external region and an ibalizumab (iMab) arm binding the human CD4 molecule. 10E8.4/iMab was administered intravenously (IV) or subcutaneously (SC). Safety/tolerability within 2 weeks of 10E8.4/iMab administration (primary outcome) and the pharmacokinetics (PK), antiviral activity, induction of anti-10E8.4/iMab antibodies, longitudinal CD4 + and CD8 + T cell counts and long-term safety (secondary outcomes) were evaluated. 54 participants living with HIV (PLWH) or without HIV (PLWoH) received 10E8.4/iMab or placebo. In arm 1, PLWoH received 10E8.4/iMab 0.3 mg kg −1 IV, 1 mg kg −1 SC, or 1 mg kg −1 IV ( n = 3 each). In arm 2, PLWoH received 10E8.4/iMab 3 mg kg −1 IV, 10 mg kg −1 IV or 30 mg kg −1 IV ( n = 6 each).
## Clinical Analysis & Structured Key Points
Nature Medicine published a clinical update in Research Highlights on 07 Jul 2026. The item focuses on Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial. Review the original article for the full source wording and details.
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