Safety and biologic activity of a bispecific T cell receptor targeting HIV Gag in males living with HIV: a first-in-human trial

Key elements of the IMC-M113V-103 study protocol are available at the European Union Clinical Trials Register (EudraCT 2021-002008-11). A redacted version of the IMC-M113V-103 study protocol is included in the Supplementary Information file and available at CTIS – Clinical Trials in the European Union (https://euclinicaltrials.eu). Cell-associated HIV gag RNA sequences generated in this study have been deposited in the BioSample database under BioProject PRJNA1372654 (https://www.ncbi.nlm.nih.gov/bioproject/?term=PRJNA1372654; https://trace.ncbi.nlm.nih.gov/Traces/study/?acc=SRP650654&o=acc_s%3Aa). Source data are provided with this paper.

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Authors and Affiliations

1. HIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium

   Linos Vandekerckhove & Mareva Delporte

2. Guy’s & St Thomas’ NHS Foundation Trust, London; Kings College London, London, UK

   Julie Fox

3. Department of Infectious Disease, Imperial College London; Imperial College National Institute of Health Research Biomedical Research Centre, London, UK

   Borja Mora-Peris & Sarah Fidler

4. Infectious Diseases Department, Hospital Universitari Vall d’Hebron, Barcelona, Spain

   Jordi Navarro

5. Institut de Recerca Vall d’Hebron, Barcelona, Spain

   Jordi Navarro

6. Department of Internal Medicine and Infectious Diseases, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Brussels, Belgium

   Sabine D. Allard

7. Regional Infectious Diseases Unit, North Manchester General Hospital, Manchester University NHS Foundation Trust, Manchester, UK

   Alison J. Uriel

8. Department of Infectious Diseases, Ramón y Cajal University Hospital, Madrid; Alcalá University, IRYCIS, CIBERINFEC, Madrid, Spain

   Santiago Moreno Guillén

9. Department of HIV Medicine, Chelsea and Westminster Hospital, London, UK

   Marta Boffito

10. Department of Sexual Health and HIV, King’s College Hospital NHS Foundation Trust, London, UK

    Frank A. Post

11. Hospital Clinico San Carlos-IdiSSC, Ciberinfec, Universidad Complutense, Madrid, Spain

    Vicente Estrada

12. Department of Infectious Diseases & Fundació Lluita contra la Sida, Institute for Health Science Research Germans Trias I Pujo (IGTP), Badalona, Spain

    Beatriz Mothe

13. IrsiCaixa AIDS Research Institute, Hospital Germans Trias I Pujol, Badalona, Spain

    Beatriz Mothe

14. CIBERINFEC, Madrid, Spain; UVic-UCC, Vic, Spain

    Beatriz Mothe

15. Immunocore Limited, Abingdon, UK

    Adel Benlahrech, Haseeb Rahman, James Clubley, Agatha Treveil, Jonathan Chamberlain, Rory Harrison, Miriam Hock, Sylvie Moureau, Andrew D. Whale, Zoë Wallace, Praveen K. Singh & Lucy Dorrell

16. Immunocore Limited, Gaithersburg, MD, USA

    Yuan Yuan, Jason Wustner & Kehmia Titanji

Contributions

The study was designed by Immunocore (study sponsor) in collaboration with the authors. L.V., J.F., B.M., A.B., Y.Y., J.W., A.D.W, Z.W., P.K.S., L.D., and S.F. contributed to the conception, design and planning of the study. M.D., H.R., J.Cl., J.C., R.H., M.H., S.M., Z.W., and P.K.S. performed assays. L.V., J.F., B.M-P., J.N., S.D.A., A.J.U., S.M.G., M.B., F.A.P., V.E., B.M., and S.F. enroled and treated patients and gathered data. M.D., A.B., H.R., A.T., J.C., R.H., M.H., S.M., Z.W., P.K.S., K.T., and L.D. analysed and interpreted data. A.B., A.D.W., Z.W., P.K.S., K.T., and L.D. drafted the manuscript. All authors critically reviewed iterations of the manuscript and approved the final draft for submission.

Corresponding author

Correspondence to Linos Vandekerckhove.

Competing interests

L.V. receives research grants from J&J, ViiV Healthcare and Gilead Sciences. J.N. has received fees for educational activities and/or consultancies and/or financial support for attending conferences from AbbVie, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme and ViiV Healthcare; S.D.A has received research grants and/or consulting fees from Gilead Sciences, GSK, MSD and ViiV Healthcare. A.J.U. has received financial support for attending a conference from Gilead Sciences. M.B. has received research grants and/or consulting fees from ViiV, Gilead, MSD, GSK, Novavax, Valneva, Cipla, Mylan, Janssen, and Roche. V.E. has received fees for educational activities and/or consultancies and/or financial support for attending conferences from Gilead Sciences, Janssen-Cilag, Merck Sharp and Dohme and ViiV Healthcare. B.M. has received consultancy fees from AELIX Therapeutics SL and AbbVie and speaker fees from Gilead, Janssen and ViiV Healthcare. M.D. was supported by the NIH MDC grant RID-HIV: UM1AI164561 and PO1 AI178376. A.B., H.R., A.T., J.C., R.H., M.H., Y.Y., J.W., S.M., A.D.W., Z.W., P.K.S., K.T., and L.D. were/are employees of Immunocore Ltd. The remaining authors declare no competing interests.

Peer review information

Nature Communications thanks the anonymous, reviewers for their contribution to the peer review of this work. A peer review file is available.

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