Microbial and immunological characteristics of the recipient are associated with beneficial responses to fecal microbiota transfer in patients with cancer immunotherapy-refractory solid tumors | 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 Microbial and immunological characteristics of the recipient are associated with beneficial responses to fecal microbiota transfer in patients with cancer immunotherapy-refractory solid tumors Michael Scharl, Luca Truscello, Yasser Morsy, Barbara Hubeli, and 23 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9278584/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 Fecal microbiota transfer (FMT) has recently proven to be effective in the treatment of oncologic patients being refractory to cancer immunotherapy (CI). However, the mechanisms of action and factors predicting response to FMT are unknown. Here we performed a prospective interventional clinical trial to investigate the impact of FMT from 4 donors with a complete or partial response to CI on the intestinal microbiome of 14 patients with various solid tumors, who were previously refractory to CI (NCT05273255). We found that high and stable microbiome -diversity, the presence of lysozyme+ monocytes within the intestinal tissue, elevated CD8+ T-cells and T-cell receptor diversity in the recipients’ circulation at baseline are associated with FMT benefit in combination with CI. Our findings demonstrate that FMT is a promising therapeutic option for patients with solid tumors, and that the response appears to depend on recipient-related, rather than donor-related characteristics. Health sciences/Medical research/Translational research Biological sciences/Cancer/Cancer therapy/Cancer immunotherapy Full Text Additional Declarations Yes there is potential Competing Interest. MS has shares and is co-founder of Recolony/Adaluria AG, Zurich, CH and has shares in PharmaBiome AG, Zurich, CH. MS served as Advisor for Abbvie, Gilead, Fresenius, Topadur, Takeda, Roche, Astra Zeneca, Pileje and Celltrion. MS received speaker’s honoraria from Janssen, Falk Pharma, Vifor Pharma, Pileje, Institut Allergosan and Bromatech. MS received research grants from Abbvie, Takeda, Gilead, Gnubiotics, Roche, Axalbion, Pharmabiome, Topadur, Basilea, MBiomics, Storm Therapeutics, LimmatTech, Zealand Pharma, NodThera, Calypso Biotech, Menarini, Pileje, Herbodee, Vifor. JM has intermittent project focused consultant/advisory relationships or has received speaker fees from Merck Sharp & Dohme, Novartis, Janssen, Bristol Myers Squibb and Pierre Fabre and has received travel support from Sunpharma, L’ oreal, Merck Sharp & Dohme, Bristol Myers and Squibb und Pierre Fabre outside of the submitted work. CB reports financial interests with Amgen (personal, travel accommodations, expense), Astra Zeneca (advisory board, personal), Boehringer Ingelheim (advisory board, personal), Merck KGaA (advisory board, personal), MSD Oncology (personal, travel, accommodations, expenses), MSD Oncology (personal, travel, accommodations, expenses), PharmaMar (advisory board, personal), Roche (advisory board, personal), Sanofi (advisory board, personal), Takeda (advisory board, personal), and Bayer (research grant, personal and institutional, financial interest, unrestricted research grant for translational research laboratory). RD has intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, T3 Pharma, MaxiVAX SA, Pfizer, Simcere and Iovance outside the submitted work. Senior medical advisor Oncobit. Participation on Derma2go. ACF declares consultation/advisory role for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Medscape, Merck Sharp and Dohme, Roche/Genentech, Takeda. ACF performed talks in a company’s organized public event: Amgen, AstraZeneca, Bristol-Myers Squibb, Daiichi-Sankyo; Foundation Medicine, J&J, Medscape, Merck Sharp and Dohme, Novocure (and travel), PharmaMar, Roche/Genentech, Takeda. ACF is the receipt of grants/research supports: (institutional support for clinical trials) sponsored by Amgen, AstraZeneca, Bristol-Myers Squibb, CatalyM, Merck Sharp and Dohme, Novocure, RevMed, Roche/Genentech Supplementary Files CleanAMENDMENTX3FMTStudyProtocolv1.627112023.pdf Study Protocol, final version TableS5Xeniumgenepanel270326.xlsx Supplementary table 5 Supplementaryfinalforsubmission30032026.docx Supplementary Figures and tables Supplementarytable6markergenes270326.xlsx Supplementary table 6 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. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9278584","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":616697864,"identity":"1f8e83e1-5211-44ef-87d6-8453e6d77c90","order_by":0,"name":"Michael 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MS served as Advisor for Abbvie, Gilead, Fresenius, Topadur, Takeda, Roche, Astra Zeneca, Pileje and Celltrion. MS received speaker’s honoraria from Janssen, Falk Pharma, Vifor Pharma, Pileje, Institut Allergosan and Bromatech. MS received research grants from Abbvie, Takeda, Gilead, Gnubiotics, Roche, Axalbion, Pharmabiome, Topadur, Basilea, MBiomics, Storm Therapeutics, LimmatTech, Zealand Pharma, NodThera, Calypso Biotech, Menarini, Pileje, Herbodee, Vifor. JM has intermittent project focused consultant/advisory relationships or has received speaker fees from Merck Sharp \u0026 Dohme, Novartis, Janssen, Bristol Myers Squibb and Pierre Fabre and has received travel support from Sunpharma, L’ oreal, Merck Sharp \u0026 Dohme, Bristol Myers and Squibb und Pierre Fabre outside of the submitted work. CB reports financial interests with Amgen (personal, travel accommodations, expense), Astra Zeneca (advisory board, personal), Boehringer Ingelheim (advisory board, personal), Merck KGaA (advisory board, personal), MSD Oncology (personal, travel, accommodations, expenses), MSD Oncology (personal, travel, accommodations, expenses), PharmaMar (advisory board, personal), Roche (advisory board, personal), Sanofi (advisory board, personal), Takeda (advisory board, personal), and Bayer (research grant, personal and institutional, financial interest, unrestricted research grant for translational research laboratory). RD has intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp \u0026 Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, T3 Pharma, MaxiVAX SA, Pfizer, Simcere and Iovance outside the submitted work. Senior medical advisor Oncobit. Participation on Derma2go. ACF declares consultation/advisory role for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Medscape, Merck Sharp and Dohme, Roche/Genentech, Takeda. ACF performed talks in a company’s organized public event: Amgen, AstraZeneca, Bristol-Myers Squibb, Daiichi-Sankyo; Foundation Medicine, J\u0026J, Medscape, Merck Sharp and Dohme, Novocure (and travel), PharmaMar, Roche/Genentech, Takeda. ACF is the receipt of grants/research supports: (institutional support for clinical trials) sponsored by Amgen, AstraZeneca, Bristol-Myers Squibb, CatalyM, Merck Sharp and Dohme, Novocure, RevMed, Roche/Genentech","formattedTitle":"Microbial and immunological characteristics of the recipient are associated with beneficial responses to fecal microbiota transfer in patients with cancer immunotherapy-refractory solid tumors","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":"
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