{ "patent_number": "US 12163952", "country": "US", "title": "Predicting and Treating Dangerous Side Effects in CAR T-Cell Therapy", "original_title": "Determining toxicity risk in CAR T-cell therapy", "summary": "This patent describes methods to identify patients at high risk for severe side effects, like cytokine release syndrome or neurotoxicity, during CAR T-cell cancer therapy and how to treat them proactively.", "what_it_does": "This patent outlines a method to reduce severe side effects, specifically severe cytokine release syndrome (CRS) or severe neurotoxicity, in patients receiving CAR T-cell therapy. The method involves administering a specific dose of CAR-expressing T cells, between 1.0x10^7 and 1x10^8 total cells. After the cells are given, the patient's blood is checked. If the CAR T-cells show a rapid expansion within about seven days (Claim 1), or if the level of interleukin-15 (IL-15) is high (at or above 30 pg/mL) within five days (Claim 2), or if specific CAR T-cell counts are met at certain days (e.g., at least 15 cells per microliter by day seven, Claim 16), the patient is identified as being at risk. Once identified, the patient is treated with an agent like a steroid (such as dexamethasone, Claim 9) or an IL-6 or IL-6 receptor inhibitor (like tocilizumab, Claim 10) to prevent or manage these severe toxicities.", "what_it_does_not_cover": [ "Does not cover CAR T-cell doses outside the specified range of 1.0x10^7 to 1x10^8 total cells.", "Does not cover treating toxicities other than severe cytokine release syndrome or severe neurotoxicity.", "Does not cover methods of toxicity management that do not involve administering a steroid or an IL-6 or IL-6 receptor inhibitor.", "Does not cover risk assessment methods that do not rely on CAR T-cell expansion timing, specific cell counts at defined days, or IL-15 levels.", "Does not cover CAR T-cell therapies where the CAR targets antigens unrelated to B cell malignancies, unless they are specifically listed antigens like CD19 or CD20." ], "filed": "2018-02-27", "granted": "2024-12-10", "expires": "2038-02-27", "status": "active", "holder": "Juno Therapeutics", "holder_url": "https://patentbrief.org/company/juno-therapeutics", "inventors": [ { "name": "Mark Gilbert", "url": "https://patentbrief.org/inventor/mark-gilbert" }, { "name": "Nathan Yee", "url": "https://patentbrief.org/inventor/nathan-yee" }, { "name": "Richard James GETTO, Jr.", "url": "https://patentbrief.org/inventor/richard-james-getto-jr" }, { "name": "Brian CHRISTIN", "url": "https://patentbrief.org/inventor/brian-christin" }, { "name": "Andrew W. WALKER", "url": "https://patentbrief.org/inventor/andrew-w-walker" }, { "name": "Valerie Odegard", "url": "https://patentbrief.org/inventor/valerie-odegard" }, { "name": "Nathaniel CHARTRAND", "url": "https://patentbrief.org/inventor/nathaniel-chartrand" }, { "name": "Ryan P. LARSON", "url": "https://patentbrief.org/inventor/ryan-p-larson" }, { "name": "Christopher Glen RAMSBORG", "url": "https://patentbrief.org/inventor/christopher-glen-ramsborg" }, { "name": "Tom KOWSKI", "url": "https://patentbrief.org/inventor/tom-kowski" }, { "name": "Jeff Smith", "url": "https://patentbrief.org/inventor/jeff-smith" }, { "name": "Nathaniel LAMBERT", "url": "https://patentbrief.org/inventor/nathaniel-lambert" }, { "name": "Nikolaus Sebastian TREDE", "url": "https://patentbrief.org/inventor/nikolaus-sebastian-trede" }, { "name": "Mel DAVIS-PICKETT", "url": "https://patentbrief.org/inventor/mel-davis-pickett" }, { "name": "Mary MALLANEY", "url": "https://patentbrief.org/inventor/mary-mallaney" }, { "name": "Samuel Charles Blackman", "url": "https://patentbrief.org/inventor/samuel-charles-blackman" }, { "name": "Kathryn Lindsay Pollock", "url": "https://patentbrief.org/inventor/kathryn-lindsay-pollock" }, { "name": "Michael Gerard COVINGTON", "url": "https://patentbrief.org/inventor/michael-gerard-covington" }, { "name": "Clinton WEBER", "url": "https://patentbrief.org/inventor/clinton-weber" }, { "name": "Kedar Himanshu DAVE", "url": "https://patentbrief.org/inventor/kedar-himanshu-dave" }, { "name": "Pascal BEAUCHESNE", "url": "https://patentbrief.org/inventor/pascal-beauchesne" }, { "name": "James Boyd WHITMORE", "url": "https://patentbrief.org/inventor/james-boyd-whitmore" }, { "name": "He Li", "url": "https://patentbrief.org/inventor/he-li" }, { "name": "Claire SUTHERLAND", "url": "https://patentbrief.org/inventor/claire-sutherland" }, { "name": "Travis BECKETT", "url": "https://patentbrief.org/inventor/travis-beckett" } ], "times_cited": 0, "tags": [ "biotech", "pharmaceutical", "gene_editing", "oncology" ], "abstract": "Provided herein are methods, compositions and articles of manufacture for use in connection with cell therapy involving the administration of one or more doses of a therapeutic T cell composition. The cells of the T cell composition express recombinant receptors such as chimeric receptors, e.g. chimeric antigen receptors (CARs) or other transgenic receptors such as T cell receptors (TCRs). Features of the provided embodiments, including the numbers of cells or units of cells administered and/or the potency of administered cells, provide various advantages, such as lower risk of toxicity in subjects administered the T cell compositions.", "url": "https://patentbrief.org/patent/us/12163952/determining-toxicity-risk-in-car-t-cell-therapy", "markdown_url": "https://patentbrief.org/patent/us/12163952/determining-toxicity-risk-in-car-t-cell-therapy/md", "google_patents_url": "https://patents.google.com/patent/US12163952", "relatedPatents": [ { "patentNumber": "9481728", "countryCode": "US", "title": "How Genetically Modified T-Cells Fight CD19 Cancers", "url": "https://patentbrief.org/patent/us/9481728/compositions-and-methods-for-treatment-of-cancer" }, { "patentNumber": "9328156", "countryCode": "US", "title": "How Genetically Modified T-Cells Attack Cancer", "url": "https://patentbrief.org/patent/us/9328156/use-of-chimeric-antigen-receptor-modified-t-cells-to-treat-cancer" }, { "patentNumber": "12168044", "countryCode": "US", "title": "Treating Liver Cancer with Specially Trained Immune Cells", "url": "https://patentbrief.org/patent/us/12168044/peptides-and-combination-of-peptides-for-use-in-immunotherapy-against-non-small-" }, { "patentNumber": "10314897", "countryCode": "US", "title": "How a Specific Protein Fragment Can Train Immune Cells to Fight Cancer", "url": "https://patentbrief.org/patent/us/10314897/peptides-and-combination-of-peptides-for-use-in-immunotherapy-against-various-ca" }, { "patentNumber": "10472419", "countryCode": "US", "title": "How Novartis Engineered Antibodies to Block the TIM-3 Immune Checkpoint", "url": "https://patentbrief.org/patent/us/10472419/keytruda-pembrolizumab" } ] }