{"schema_version":"1.0","type":"article","title":"CAR-T 迎接新時代：從血癌走向自體免疫","url":"https://drugnews.com.tw/articles/2026-06-08-cart-autoimmune-new-era.html","markdown_url":"https://drugnews.com.tw/articles/2026-06-08-cart-autoimmune-new-era.md","lang":"zh-Hant","date":"2026-06-08","publish_at":"2026-06-08T10:30:00+08:00","updated_at":"2026-06-08","category":"商業分析系列","topic":"臨床與 CMC","tags":["CAR-T","自體免疫","Kyverna","mivocabtagene autoleucel","細胞治療","FDA"],"summary":"Kyverna 啟動 mivocabtagene autoleucel 的 BLA 滾動式提交，象徵 CAR-T 從血癌治療走向自體免疫疾病的新階段，也重新打開細胞治療的商業想像。","key_points":[],"facts":[],"sections":["01｜ 為什麼是 SPS？因為這是一個小市場，但痛點極深的切入口","02｜🔄 miv-cel 的核心不是「壓制免疫」，而是試圖重置免疫系統","03｜SPS 只是起點，真正的市場在更大的 B cell-driven autoimmune diseases","04｜BMS、Cartesian 也在衝：自體免疫 CAR-T 已經進入全球臨床競速","05｜下一波更大的想像：in vivo CAR-T","06｜自體免疫 CAR-T 的三重門：安全、持久、可及","07｜台灣可以怎麼看？再生醫療產業升級的方向？","結語｜CAR-T 的下一個時代，不只是殺癌細胞，而是重置免疫系統"],"references":[{"title":"[0]: 各公司官網＆公開資料","source":"","date":"","url":""},{"title":"[1]:","source":"","date":"","url":""},{"title":"ir.kyvernatx.com","source":"","date":"","url":""},{"title":"https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-initiation-rolling-sps-bla","source":"","date":"","url":"https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-initiation-rolling-sps-bla"},{"title":"ir.kyvernatx.com","source":"","date":"","url":""},{"title":"\"Kyverna Therapeutics Announces Initiation of Rolling SPS BLA Submission and Reports First Quarter 2026 Financial Results","source":"Kyverna Therapeutics\"","date":"","url":""},{"title":"[2]:","source":"","date":"","url":""},{"title":"Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical Benefit Across All Endpoints in an Oral, Late-Breaker Session at AAN Annual Meeting","source":"Taiwan News","date":"","url":""},{"title":"| Apr. 22, 2026 06:45","source":"","date":"","url":""},{"title":"www.taiwannews.com.tw","source":"","date":"","url":""},{"title":"\"Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical Benefit Across All Endpoints in an Oral, Late-Breaker Session at AAN Annual Meeting","source":"Taiwan News","date":"","url":""},{"title":"[3]:","source":"","date":"","url":""},{"title":"External Link Icon","source":"","date":"","url":""},{"title":"The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis","source":"","date":"","url":""},{"title":"www.bmsstudyconnect.com","source":"","date":"","url":""},{"title":"\"Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of ...\"","source":"","date":"","url":""},{"title":"[4]:","source":"","date":"","url":""},{"title":"ir.cartesiantherapeutics.com","source":"","date":"","url":""},{"title":"https://ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-highlights-recent-progress-and-outlines","source":"","date":"","url":"https://ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-highlights-recent-progress-and-outlines"},{"title":"ir.cartesiantherapeutics.com","source":"","date":"","url":""},{"title":"\"Cartesian Therapeutics Highlights Recent Progress and Outlines 2026 Outlook - Cartesian Therapeutics, Inc\"","source":"","date":"","url":""},{"title":"[5]:","source":"","date":"","url":""},{"title":"AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology - Jun 30, 2025","source":"","date":"","url":""},{"title":"Capstan's lead asset, CPTX2309, is a targeted lipid nanoparticle (tLNP) that delivers an mRNA encoding an anti-CD19 chimeric antigen receptor (CAR) to CD8-expressing cytotoxic T cells in vivo, and...","source":"","date":"","url":""},{"title":"news.abbvie.com","source":"","date":"","url":""},{"title":"\"AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology - Jun 30, 2025\"","source":"","date":"","url":""},{"title":"[6]:","source":"","date":"","url":""},{"title":"Bristol Myers Squibb - Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics","source":"","date":"","url":""},{"title":"Acquisition includes OTX-201, an investigational next-generation CAR T-cell therapy designed to reprogram cells in vivo with potential best-in-class profile for autoimmune diseases Transaction further strengthens BMS’s industry-leading cell therapy portfo","source":"","date":"","url":""},{"title":"news.bms.com","source":"","date":"","url":""},{"title":"\"","source":"","date":"","url":""},{"title":"Bristol Myers Squibb - Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics\"","source":"","date":"","url":""}],"images":[{"alt":"Kyverna 的 miv-cel 推動 CAR-T 從血癌治療走向自體免疫疾病，SPS 是第一個商業化門口。","url":"https://drugnews.com.tw/assets/articles/cart-autoimmune-new-era/dcard-01.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/cart-autoimmune-new-era/dcard-01.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-06-08）。CAR-T 迎接新時代：從血癌走向自體免疫。https://drugnews.com.tw/articles/2026-06-08-cart-autoimmune-new-era.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{"en":"2026-06-08-cart-autoimmune-new-era-en.html"},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}