Evidence map›Paper›PMID 42414619›Full record

Trial reportNature medicine2026

Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial.

Deborah A Theodore, Bryan T Mayer, Charlotte-Paige Rolle, Edwin DeJesus, Margaret E Ackerman, Michael S Seaman, Joshua Alex Weiner, Hiroshi Mohri, Yaoxing Huang, Brett Gray and 18 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Deborah A Theodore *Division of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. dat2132@cumc.columbia.edu.ORCID http://orcid.org/0000-0001-8998-113X
Bryan T Mayer *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2258-5276
Charlotte-Paige RolleOrlando Immunology Center, Orlando, FL, USA.
Edwin DeJesusOrlando Immunology Center, Orlando, FL, USA.
Margaret E AckermanDepartment of Microbiology and Immunology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.ORCID http://orcid.org/0000-0002-4253-3476
Michael S SeamanCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Joshua Alex WeinerThayer School of Engineering, Dartmouth College, Hanover, NH, USA.ORCID http://orcid.org/0000-0003-1054-0628
Hiroshi MohriDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Yaoxing HuangDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.ORCID http://orcid.org/0000-0001-6270-1644
Brett GrayDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Jennifer ChangDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Monica W GerberVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0001-9878-9166
Jian YuDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Yang LuoDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.ORCID http://orcid.org/0000-0003-3277-8792
Neal N PadteDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Michael T YinDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Burc BarinThe Emmes Company, LLC, Rockville, MD, USA.
Rusty GreeneDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Steven PalmerDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Ariana PazminoDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Jorge BenitezDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Carlie DorrDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Meredith McNairyDivision of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
James DiRenzoDepartment of Molecular and Systems Biology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
Chanc VanWinkle OrzellThayer School of Engineering, Dartmouth College, Hanover, NH, USA.
David D Ho *Division of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.ORCID http://orcid.org/0000-0003-1627-149X
Ollivier Hyrien *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-1909-2542
Magdalena E Sobieszczyk *Division of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.

Funding

Bill & Melinda Gates Foundation INV-032929Bill & Melinda Gates Foundation INV-036842Gates Foundation INV-032929Gates Foundation INV-036842
6 · The paper itself

Abstract

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

Indexed as

Antibodies, BispecificAntibodies, NeutralizingBroadly Neutralizing AntibodiesHIV-1HIV AntibodiesHIV InfectionsAdultAntibodies, MonoclonalCD4-Positive T-LymphocytesFemaleHumansMaleMiddle AgedAntibodies, BispecificAntibodies, MonoclonalAntibodies, NeutralizingBroadly Neutralizing AntibodiesHIV Antibodiesibalizumab

Identifiers

PMID42414619
PMCPMC13375543

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.