Cell-derived Nanoparticles Provide a Robust Platform to Manufacture Therapeutic T cells.

Cell-derived Nanoparticles Provide a Robust Platform to Manufacture Therapeutic T cells. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Cell-derived Nanoparticles Provide a Robust Platform to Manufacture Therapeutic T cells. James Riley, Mosha Deng, Tanishk Sinha, Meizan Lai, Shuguang Jiang, and 30 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8436008/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted You are reading this latest preprint version Abstract Some patients cannot receive T cell therapies because their cells are unable to be manufactured. To address this limitation, we developed K562-based artificial antigen-presenting cells (aAPCs) expressing an OKT3-derived scFv for TCR stimulation, CD86 and 4-1BBL for costimulation, and membrane-bound IL-7 and IL-15Rα/IL-15 for cytokine support. From these aAPCs, we generated cell-derived nanoparticles (CDNPs) that accelerated T cell entry into the cell cycle compared with CD3/28-coated beads, enabling efficient concurrent activation and lentiviral transduction. CDNPs robustly expanded T cells from patients whose products could not be manufactured using standard approaches, and these CDNP-derived CAR T cells controlled tumors in humanized mouse models. In a phase I trial of patients with CD19⁺ malignancies (NCT04684563), cGMP-compatible CDNPs enabled streamlined 3-day manufacturing of IL-18–expressing CD19 CAR T cells, yielding higher cell recovery and durable clinical responses without unexpected toxicities, supporting CDNPs as a platform for commercial CAR T cell production. Biological sciences/Immunology/Immunotherapy Biological sciences/Biotechnology/Cell delivery Full Text Additional Declarations Yes there is potential Competing Interest. CH, VC, PK are employees and hold equity in BlueWhale Bio. JKJ is a paid consultant for BlueWhale Bio. JAF holds patents and intellectual property in T cell-based cancer immunotherapy with royalties; receives funding from Tmunity Therapeutics and Danaher Corporation; consultancy with Retro Biosciences; scientific advisory board memberships with Cartography Bio, Shennon Biotechnologies Inc., CellFe Biotech, OverT Bio, Inc., and Tceleron Therapeutics, Inc. NCS is eligible to receive milestone-based payments from Kite Pharma, a Gilead company, holds equity in and is a Scientific Advisory Board member for BlueWhale Bio, CARTx Therapeutics, and Waypoint Bio. He is also a member of the Scientific Advisory Board for PanCancer-T. He has received advisory fees from BlueWhale Bio, PanCancer-T, Urogen Pharma, and Waypoint Bio. MMD received royalties/milestones payments from Novartis Institute for Biomedical Research; received royalties/milestones, consultant fees and received research funding from Tmunity Therapeutics/Kite Pharma; is a consultant, member on Scientific Advisory Board, and received research funding from Cellares Corporation, and is a consultant, member on Scientific Advisory Board, received research funding, and a equity holder for BlueWhale Bio. A.C. is a scientific adviser and holds equity in BlueWhale Bio, and is eligible to receive milestone-based payments from Kite Pharma, a Gilead company. NVF reports a consultant or advisory role for Kite, a Gilead Company, Mneumo Therapeutics, Pfizer, and Sana Biotechnology, and research funding from Novartis. JS is a consultant for Pfizer, Pharmacyclics, Incyte, Genmab, BMS, Atara, and Astra Zeneca and receives research funding from Pharmacyclics, Merck, Incyte, BMS, Astra Zeneca, and Kite, CHJ is a scientific co-founder and holds equity in Capstan Therapeutics, Dispatch Biotherapeutics, and BlueWhale Bio; serves on the board of AC Immune; and is a scientific advisor to BlueSphere Bio, Cabaletta, Carisma, Cartography, Cellares, CellCarta, Celldex, Danaher, Decheng, ImmuneSensor, Kite Pharma, Poseida, Verismo, Viracta, ViTToria, and WIRB-Copernicus Group. J.L.R. is a scientific co-founder of, holds equity in, and receives research funding from BlueWhale Bio and is eligible to receive milestone-based payments from Kite Pharma, a Gilead company. The other authors declare no competing interests. Cite Share Download PDF Status: Under Review Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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JKJ is a paid consultant for BlueWhale Bio. JAF holds patents and intellectual property in T cell-based cancer immunotherapy with royalties; receives funding from Tmunity Therapeutics and Danaher Corporation; consultancy with Retro Biosciences; scientific advisory board memberships with Cartography Bio, Shennon Biotechnologies Inc., CellFe Biotech, OverT Bio, Inc., and Tceleron Therapeutics, Inc. NCS is eligible to receive milestone-based payments from Kite Pharma, a Gilead company, holds equity in and is a Scientific Advisory Board member for BlueWhale Bio, CARTx Therapeutics, and Waypoint Bio. He is also a member of the Scientific Advisory Board for PanCancer-T. He has received advisory fees from BlueWhale Bio, PanCancer-T, Urogen Pharma, and Waypoint Bio. MMD received royalties/milestones payments from Novartis Institute for Biomedical Research; received royalties/milestones, consultant fees and received research funding from Tmunity Therapeutics/Kite Pharma; is a consultant, member on Scientific Advisory Board, and received research funding from Cellares Corporation, and is a consultant, member on Scientific Advisory Board, received research funding, and a equity holder for BlueWhale Bio. A.C. is a scientific adviser and holds equity in BlueWhale Bio, and is eligible to receive milestone-based payments from Kite Pharma, a Gilead company. NVF reports a consultant or advisory role for Kite, a Gilead Company, Mneumo Therapeutics, Pfizer, and Sana Biotechnology, and research funding from Novartis. JS is a consultant for Pfizer, Pharmacyclics, Incyte, Genmab, BMS, Atara, and Astra Zeneca and receives research funding from Pharmacyclics, Merck, Incyte, BMS, Astra Zeneca, and Kite, CHJ is a scientific co-founder and holds equity in Capstan Therapeutics, Dispatch Biotherapeutics, and BlueWhale Bio; serves on the board of AC Immune; and is a scientific advisor to BlueSphere Bio, Cabaletta, Carisma, Cartography, Cellares, CellCarta, Celldex, Danaher, Decheng, ImmuneSensor, Kite Pharma, Poseida, Verismo, Viracta, ViTToria, and WIRB-Copernicus Group. J.L.R. is a scientific co-founder of, holds equity in, and receives research funding from BlueWhale Bio and is eligible to receive milestone-based payments from Kite Pharma, a Gilead company. The other authors declare no competing interests.","formattedTitle":"Cell-derived Nanoparticles Provide a Robust Platform to Manufacture Therapeutic T cells.","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"nature-portfolio","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"","title":"Nature Portfolio","twitterHandle":"","acdcEnabled":false,"dfaEnabled":false,"editorialSystem":"ejp","reportingPortfolio":"","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-8436008/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8436008/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"Some patients cannot receive T cell therapies because their cells are unable to be manufactured. To address this limitation, we developed K562-based artificial antigen-presenting cells (aAPCs) expressing an OKT3-derived scFv for TCR stimulation, CD86 and 4-1BBL for costimulation, and membrane-bound IL-7 and IL-15Rα/IL-15 for cytokine support. From these aAPCs, we generated cell-derived nanoparticles (CDNPs) that accelerated T cell entry into the cell cycle compared with CD3/28-coated beads, enabling efficient concurrent activation and lentiviral transduction. CDNPs robustly expanded T cells from patients whose products could not be manufactured using standard approaches, and these CDNP-derived CAR T cells controlled tumors in humanized mouse models. 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