Phase 1 study to determine the safety and dosing of autologous PBMCs modified to present HPV16 antigens (SQZ-PBMC-HPV) in HLA-A*02+ patients with HPV16+ solid tumors.
Antigen presenting cell
Cancer vaccine
Cellular therapy
HPV16
Immunotherapy
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
received:
07
12
2022
accepted:
15
02
2023
medline:
1
5
2023
pubmed:
4
3
2023
entrez:
3
3
2023
Statut:
ppublish
Résumé
We conducted a dose escalation Phase 1 study of autologous PBMCs loaded by microfluidic squeezing (Cell Squeeze
Identifiants
pubmed: 36867316
doi: 10.1007/s10637-023-01342-x
pii: 10.1007/s10637-023-01342-x
pmc: PMC10140074
mid: NIHMS1895206
doi:
Substances chimiques
HLA-A Antigens
0
Oncogene Proteins, Viral
0
Papillomavirus E7 Proteins
0
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
284-295Subventions
Organisme : NCI NIH HHS
ID : K12 CA090625
Pays : United States
Informations de copyright
© 2023. The Author(s).
Références
Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M (2019) Human Papillomavirus-Attributable Cancers - United States, 2012–2016. Morb Mortal Wkly Rep 68:724–728
doi: 10.15585/mmwr.mm6833a3
Ressing ME, Sette A, Brandt RM, Ruppert J, Wentworth PA, Hartman M et al (1995) Human CTL epitopes encoded by human papillomavirus type 16 E6 and E7 identified through in vivo and in vitro immunogenicity studies of HLA-A*0201-binding peptides. J Immunol 154:5934–5943
doi: 10.4049/jimmunol.154.11.5934
pubmed: 7538538
Wang X, Sandberg ML, Martin AD, Negri KR, Gabrelow GB, Nampe DP et al (2021) Potent, selective CARs as potential t-cell therapeutics for HPV-positive cancers. J Immunother 44:292–306
doi: 10.1097/CJI.0000000000000386
pubmed: 34432728
pmcid: 8415731
Ferreiro-Iglesias A, McKay JD, Brenner N, Virani S, Lesseur C, Gaborieau V et al (2021) Germline determinants of humoral immune response to HPV-16 protect against oropharyngeal cancer. Nat Commun 12:5945
doi: 10.1038/s41467-021-26151-9
pubmed: 34642315
pmcid: 8511029
Sharei A, Trifonova R, Jhunjhunwala S, Hartoularos GC, Eyerman AT, Lytton-Jean A et al (2015) Ex vivo cytosolic delivery of functional macromolecules to immune cells. PLoS ONE 10:e0118803
doi: 10.1371/journal.pone.0118803
pubmed: 25875117
pmcid: 4395260
Sharei A, Zoldan J, Adamo A, Sim WY, Cho N, Jackson E et al (2013) A vector-free microfluidic platform for intracellular delivery. Proc Natl Acad Sci U S A 110:2082–2087
doi: 10.1073/pnas.1218705110
pubmed: 23341631
pmcid: 3568376
DiTommaso T, Cole JM, Cassereau L, Bugge JA, Hanson JLS, Bridgen DT et al (2018) Cell engineering with microfluidic squeezing preserves functionality of primary immune cells in vivo. Proc Natl Acad Sci U S A 115:E10907–E10914
doi: 10.1073/pnas.1809671115
pubmed: 30381459
pmcid: 6243275
Booty MG, Hlavaty KA, Stockmann A, Ozay EI, Smith C, Tian L et al (2022) Microfluidic squeezing enables MHC Class I antigen presentation by diverse immune cells to elicit CD8(+) T cell responses with antitumor activity. J Immunol 208:929–940
doi: 10.4049/jimmunol.2100656
pubmed: 35091434
pmcid: 9012083
Lin KY, Guarnieri FG, Staveley-O’Carroll KF, Levitsky HI, August JT, Pardoll DM et al (1996) Treatment of established tumors with a novel vaccine that enhances major histocompatibility class II presentation of tumor antigen. Cancer Res 56:21–26
pubmed: 8548765
Maiers M, Gragert L, Klitz W (2007) High-resolution HLA alleles and haplotypes in the United States population. Hum Immunol 68:779–788
doi: 10.1016/j.humimm.2007.04.005
pubmed: 17869653
Maiers M, Gragert L, Klitz W. (2007) National marrow donor program: high-resolution HLA alleles and haplotypes in the US population. https://bioinformatics.bethematchclinical.org/hla-resources/haplotype-frequencies/high-resolution-hla-alleles-and-haplotypes-in-the-us-population/ . Accessed 11 Apr 2022
Tertipis N, Villabona L, Nordfors C, Nasman A, Ramqvist T, Vlastos A et al (2014) HLA-A*02 in relation to outcome in human papillomavirus positive tonsillar and base of tongue cancer. Anticancer Res 34:2369–2375
pubmed: 24778045
Nasman A, Andersson E, Marklund L, Tertipis N, Hammarstedt-Nordenvall L, Attner P et al (2013) HLA class I and II expression in oropharyngeal squamous cell carcinoma in relation to tumor HPV status and clinical outcome. PLoS ONE 8:e77025
doi: 10.1371/journal.pone.0077025
pubmed: 24130830
pmcid: 3794938
Chabeda A, Yanez RJR, Lamprecht R, Meyers AE, Rybicki EP, Hitzeroth II (2018) Therapeutic vaccines for high-risk HPV-associated diseases. Papillomavirus Res 5:46–58
doi: 10.1016/j.pvr.2017.12.006
pubmed: 29277575
(2022) PubChem Compound Summary for CID 56841790, ProMune. https://pubchem.ncbi.nlm.nih.gov/compound/ProMune . Updated 16 Apr 2022, Accessed 18 Apr 2022
Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S et al (2017) iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol 18:e143–e152
doi: 10.1016/S1470-2045(17)30074-8
pubmed: 28271869
pmcid: 5648544
Hegde PS, Karanikas V, Evers S (2016) The where, the when, and the how of immune monitoring for cancer immunotherapies in the era of checkpoint inhibition. Clin Cancer Res 22:1865–1874
doi: 10.1158/1078-0432.CCR-15-1507
pubmed: 27084740
(2017) PROVENGE
Harndahl M, Rasmussen M, Roder G, Dalgaard Pedersen I, Sorensen M, Nielsen M et al (2012) Peptide-MHC class I stability is a better predictor than peptide affinity of CTL immunogenicity. Eur J Immunol 42:1405–1416
doi: 10.1002/eji.201141774
pubmed: 22678897
Riley RS, June CH, Langer R, Mitchell MJ (2019) Delivery technologies for cancer immunotherapy. Nat Rev Drug Discov 18:175–196
doi: 10.1038/s41573-018-0006-z
pubmed: 30622344
pmcid: 6410566
Bonifant CL, Jackson HJ, Brentjens RJ, Curran KJ (2016) Toxicity and management in CAR T-cell therapy. Mol Ther Oncolytics 3:16011
doi: 10.1038/mto.2016.11
pubmed: 27626062
pmcid: 5008265
Cruz FM, Colbert JD, Merino E, Kriegsman BA, Rock KL (2017) The biology and underlying mechanisms of cross-presentation of exogenous antigens on MHC-I molecules. Annu Rev Immunol 35:149–176
doi: 10.1146/annurev-immunol-041015-055254
pubmed: 28125356
pmcid: 5508990
McLane LM, Abdel-Hakeem MS, Wherry EJ (2019) CD8 T cell exhaustion during chronic viral infection and cancer. Annu Rev Immunol 37:457–495
doi: 10.1146/annurev-immunol-041015-055318
pubmed: 30676822
Krishna S, Ulrich P, Wilson E, Parikh F, Narang P, Yang S et al (2018) Human papilloma virus specific immunogenicity and dysfunction of CD8(+) T cells in head and neck cancer. Cancer Res 78:6159–6170
doi: 10.1158/0008-5472.CAN-18-0163
pubmed: 30154146
Liu J, Fu M, Wang M et al (2022) Cancer vaccines as promising immuno-therapeutics: platforms and current progress. J Hematol Oncol 15:28
doi: 10.1186/s13045-022-01247-x
pubmed: 35303904
pmcid: 8931585
Zaretsky JM, Garcia-Diaz A, Shin DS et al (2016) Mutations associated with acquired resistance to PD-1 blockade in melanoma. N Engl J Med 375(9):819–829
doi: 10.1056/NEJMoa1604958
pubmed: 27433843
pmcid: 5007206
Sade-Feldman M, Jiao YJ, Chen JH et al (2017) Resistance to checkpoint blockade therapy through inactivation of antigen presentation. Nat Commun 8(1):1136 (Published 2017 Oct 26)
doi: 10.1038/s41467-017-01062-w
pubmed: 29070816
pmcid: 5656607
Saxena M, van der Burg SH, Melief CJM et al (2021) Therapeutic cancer vaccines. Nat Rev Cancer 21:360–378
doi: 10.1038/s41568-021-00346-0
pubmed: 33907315
Hlavaty KA, Booty MG, Loughhead S, et al (2019) Abstract 3187: Engineering a new generation of cell therapies for solid tumor oncology using the SQZ platform. Cancer Res 79 (13_Supplement):3187
Gupta S, Carballido E, Fishman M (2011) Sipuleucel-T for therapy of asymptomatic or minimally symptomatic, castrate-refractory prostate cancer: an update and perspective among other treatments. Onco Targets Ther 4:79–96. https://doi.org/10.2147/OTT.S14107
doi: 10.2147/OTT.S14107
pubmed: 21792315
pmcid: 3143908
Shafer P, Kelly LM, Hoyos V (2022) Cancer therapy With TCR-engineered T Cells: current strategies, challenges, and prospects. Front Immunol 13:835762
doi: 10.3389/fimmu.2022.835762
pubmed: 35309357
pmcid: 8928448
Vormittag P, Gunn R, Ghorashian S, Veraitch FS (2018) A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol 53:164–181
doi: 10.1016/j.copbio.2018.01.025
pubmed: 29462761
Wang S, Sun J, Chen K, Ma P, Lei Q, Xing S et al (2021) Perspectives of tumor-infiltrating lymphocyte treatment in solid tumors. BMC Med 19:140
doi: 10.1186/s12916-021-02006-4
pubmed: 34112147
pmcid: 8194199
Tran KQ, Zhou J, Durflinger KH, Langhan MM, Shelton TE, Wunderlich JR et al (2008) Minimally cultured tumor-infiltrating lymphocytes display optimal characteristics for adoptive cell therapy. J Immunother 31:742–751
doi: 10.1097/CJI.0b013e31818403d5
pubmed: 18779745
pmcid: 2614999
Burch PA, Breen JK, Buckner JC, Gastineau DA, Kaur JA, Laus RL et al (2000) Priming tissue-specific cellular immunity in a phase I trial of autologous dendritic cells for prostate cancer. Clin Cancer Res 6:2175–2182
pubmed: 10873066
Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV et al (2000) Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 18:3894–3903
doi: 10.1200/JCO.2000.18.23.3894
pubmed: 11099318
Dadgar M, Lee C, Salmonsen D, Bernstein H, Park S (2022) Abstract 1171: A decentralized and integrated manufacturing system for the rapid and cost-effective production of cell therapy drug products. Mol Therapy 30(4):452
Bruni D, Angell HK, Galon J (2020) The immune contexture and Immunoscore in cancer prognosis and therapeutic efficacy. Nat Rev Cancer 20:662–680
doi: 10.1038/s41568-020-0285-7
pubmed: 32753728