Evidence map›Paper›PMID 40374689›Full record

ArticleNature communications2025

Autologous HIV-specific T cell therapy targeting conserved epitopes is well-tolerated in six adults with HIV: an open-label, single-arm phase 1 study.

Danielle K Sohai, Michael D Keller, Patrick J Hanley, Fahmida Hoq, Divyesh Kukadiya, Anushree Datar, Emily Reynolds, Dennis C Copertino, Christopher Lazarski, Chase D McCann and 19 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03485963 (A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03485963 phase1completednot on this map

A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection

TypeinterventionalSponsorCatherine BollardRan2019 to 2022Enrolled7ConditionsHIV InfectionsArmsHST-NEETs
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Adoptive T-cell therapy for virus-associated diseases.Clinical microbiology reviews · 2025
    Review
  4. Review
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

29 authors.

Danielle K SohaiCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0003-0186-2975
Michael D KellerCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0001-8323-3085
Patrick J HanleyCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0002-0102-7892
Fahmida HoqCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Divyesh KukadiyaCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Anushree DatarCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Emily ReynoldsCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Dennis C CopertinoInfectious Diseases Division, Department of Medicine, Weill-Cornell Medicine, New York, NY, USA.ORCID http://orcid.org/0000-0002-3217-4713
Christopher LazarskiCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0001-8917-7280
Chase D McCannCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Jay TannaCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Abeer ShibliCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Haili LangCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Anqing ZhangCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Pamela A ChanskyCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0002-8169-992X
Cecilia MottaCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.
Tan T HuynhInfectious Diseases Division, Department of Medicine, Weill-Cornell Medicine, New York, NY, USA.ORCID http://orcid.org/0009-0009-0286-3946
Bridget DwyerIntegrated Biomedical Sciences, Department of Microbiology, Immunology, and Tropical Medicine, and Department of Pediatrics, The George Washington University, Washington, DC, USA.
Andrew WilsonIntegrated Biomedical Sciences, Department of Microbiology, Immunology, and Tropical Medicine, and Department of Pediatrics, The George Washington University, Washington, DC, USA.
Rebecca LynchIntegrated Biomedical Sciences, Department of Microbiology, Immunology, and Tropical Medicine, and Department of Pediatrics, The George Washington University, Washington, DC, USA.
Talia M MotaInfectious Diseases Division, Department of Medicine, Weill-Cornell Medicine, New York, NY, USA.
Winiffer D Conce AlbertoInfectious Diseases Division, Department of Medicine, Weill-Cornell Medicine, New York, NY, USA.
Zabrina L BrummeFaculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada.ORCID http://orcid.org/0000-0002-8157-1037
Natalie N KinlochFaculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada.
Conrad Russell Y CruzCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0001-7065-3769
Lynsay MacLaren EhuiWhitman-Walker Health, Washington, DC, USA.
Sarah HennWhitman-Walker Health, Washington, DC, USA.
R Brad JonesInfectious Diseases Division, Department of Medicine, Weill-Cornell Medicine, New York, NY, USA.ORCID http://orcid.org/0000-0003-4470-1231
Catherine M BollardCenter for Cancer and Immunology Research, and Division of Biostatistics and Study Methodology, Children's National Hospital, Washington, DC, USA. cbollard@childrensnational.org.ORCID http://orcid.org/0000-0001-5140-9090

Funding

U.S. Department of Health & Human Services | National Institutes of Health (NIH) 5UM1AI126617-04
6 · The paper itself

Abstract

Novel cellular therapies may enable HIV control or cure. HIV-specific T cells targeting conserved immunogenic protein regions of HIV Gag/Pol and the entirety of HIV Nef, termed HST-NEETs, eliminate HIV infected cells in vitro. Here we enroll seven participants in an open-label, single-arm phase 1 study (NCT03485963) to evaluate the safety (primary endpoint) of two autologous administrations of HST-NEET products without prescribed lymphodepletion. Adults with well-controlled HIV on anti-retroviral therapy are eligible. Six participants completed safety monitoring. No serious product-related toxicities are observed. Secondary endpoints are to assess expansion and persistence of HIV-reactive T cell clones, and changes to the HIV reservoir for each infused participant. HIV-specific T cell and HIV anti-Env antibody responses increase in two participants after infusion two. A trend towards decreasing levels of intact proviruses is observed in 2 participants. Three participants show persistence of HIV-reactive, product-associated T cell clones for ≥40 weeks post infusions. HST-NEETs infusions are well-tolerated. Future trials are needed to evaluate the efficacy of HST-NEETs in this population.

Indexed as

EpitopesHIV-1HIV InfectionsImmunotherapy, AdoptiveT-LymphocytesAdultFemaleHIV AntibodiesHumansMaleMiddle AgedEpitopesHIV Antibodies

Identifiers

PMID40374689
PMCPMC12081906

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Registered trials

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.