@article{Vandekerckhove:2026:10.1038/s41467-026-68833-2,
author = {Vandekerckhove, L and Fox, J and Mora-Peris, B and Navarro, J and Allard, SD and Uriel, AJ and Moreno, Guillén S and Boffito, M and Post, FA and Estrada, V and Mothe, B and Delporte, M and Benlahrech, A and Rahman, H and Clubley, J and Treveil, A and Chamberlain, J and Harrison, R and Hock, M and Yuan, Y and Wustner, J and Moureau, S and Whale, AD and Wallace, Z and Singh, PK and Titanji, K and Dorrell, L and Fidler, S},
doi = {10.1038/s41467-026-68833-2},
journal = {Nat Commun},
title = {Safety and biologic activity of a bispecific T cell receptor targeting HIV Gag in males living with HIV: a first-in-human trial.},
url = {http://dx.doi.org/10.1038/s41467-026-68833-2},
year = {2026}
}

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TY  - JOUR
AB  - HIV persistence in reservoirs despite antiretroviral therapy (ART) is a barrier to a permanent cure. We present the affinity-enhanced TCR bispecific IMC-M113V as a potential therapeutic for targeted HIV reservoir elimination. Preclinical studies demonstrate that IMC-M113V redirects T cells towards cells expressing the variable viral peptide, Gag77-85, presented by HLA-A02:01 at low copy number, without binding to HIV-negative cells. Here, we conduct a first-in-human, open-label single ascending dose study of IMC-M113V (1.6-15 µg) in twelve HLA-A02:01-positive males living with HIV on suppressive ART (EudraCT number 2021-002008-11). Participants receive one intravenous infusion of IMC-M113V on Day 1 and are monitored through Day 29 to evaluate safety, tolerability (primary endpoints) and pharmacodynamic (PD) activity (secondary endpoint). IMC-M113V is well tolerated and not associated with any serious adverse event. PD activity is dose-dependent and strongest in participants with highly IMC-M113V-sensitive Gag77-85 variant sequences. Thus, we provide a promising foundation to evaluate multiple and higher doses of IMC-M113V as a strategy for achieving ART-free virological control.
AU  - Vandekerckhove,L
AU  - Fox,J
AU  - Mora-Peris,B
AU  - Navarro,J
AU  - Allard,SD
AU  - Uriel,AJ
AU  - Moreno,Guillén S
AU  - Boffito,M
AU  - Post,FA
AU  - Estrada,V
AU  - Mothe,B
AU  - Delporte,M
AU  - Benlahrech,A
AU  - Rahman,H
AU  - Clubley,J
AU  - Treveil,A
AU  - Chamberlain,J
AU  - Harrison,R
AU  - Hock,M
AU  - Yuan,Y
AU  - Wustner,J
AU  - Moureau,S
AU  - Whale,AD
AU  - Wallace,Z
AU  - Singh,PK
AU  - Titanji,K
AU  - Dorrell,L
AU  - Fidler,S
DO  - 10.1038/s41467-026-68833-2
PY  - 2026///
TI  - Safety and biologic activity of a bispecific T cell receptor targeting HIV Gag in males living with HIV: a first-in-human trial.
T2  - Nat Commun
UR  - http://dx.doi.org/10.1038/s41467-026-68833-2
UR  - https://www.ncbi.nlm.nih.gov/pubmed/41620403
ER  - 

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