{"id":3540,"date":"2026-01-19T12:59:53","date_gmt":"2026-01-19T11:59:53","guid":{"rendered":"https:\/\/fhucare.com\/?page_id=3540"},"modified":"2026-02-13T13:51:37","modified_gmt":"2026-02-13T12:51:37","slug":"cell-attack","status":"publish","type":"page","link":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/","title":{"rendered":"Cell Attack"},"content":{"rendered":"\n

Academic Development of CD19 CAR T cells Therapy for Refractory Autoimmune Diseases<\/strong><\/h2>\n\n\n\n

Leaders : Cristina Castilla-Llorente<\/a><\/strong>, Camille Bigenwald<\/strong><\/a>, Samuel Bitoun<\/strong><\/a>, Xavier Mariette<\/strong><\/a><\/p>\n\n\n\n

Hematologists<\/strong>, Gustave Roussy Institute
Rheumatologists<\/strong>, Assistance Publique \u2013 H\u00f4pitaux de Paris, Bic\u00eatre Hospital<\/p>\n\n\n\n

Synopsis<\/strong><\/h3>\n\n\n\n

Refractory autoimmune diseases (RAIDs) represent a therapeutic challenge, with limited treatment options. CD19 CAR-T cell immunotherapy, initially developed for hematologic malignancies, is emerging as a promising approach to target B lymphocytes and certain plasma cells. CD19 CAR-T cells can induce treatment-free remission in these severe patients, an outcome unattainable with any other current therapy for these conditions.<\/p>\n\n\n\n

Primary Objective<\/strong><\/h3>\n\n\n\n

To develop and validate a local manufacturing process for second-generation autologous CD19 CAR-T cells in a closed system and to evaluate their safety and efficacy in the treatment of refractory autoimmune diseases.<\/p>\n\n\n\n

Methodology<\/strong><\/h3>\n\n\n\n

This study aims to produce at Gustave Roussy, within the Cellular Therapy Unit (Hematology Department, 8th floor), an autologous CD19 CAR-T cell therapy for six (6) patients<\/strong> with refractory autoimmune diseases, including lupus<\/strong>, rheumatoid arthritis<\/strong>, Sj\u00f6gren\u2019s disease<\/strong>, myositis<\/strong>, and systemic sclerosis<\/strong>.<\/p>\n\n\n\n

In collaboration with Miltenyi Biotec, the Gustave Roussy team has implemented the Prodigy system, a closed-platform device enabling the production of second-generation CD19 CAR-T cells incorporating the 4-1BB co-stimulatory domain.
The lentiviral vector, provided directly by Miltenyi and already approved by the EMA, simplifies regulatory approval procedures. Initial validation included evaluation of T cell transduction efficiency by flow cytometry and microbiological testing to ensure product sterility, including bacterial and mycoplasma detection, using T cells isolated from healthy individuals.<\/p>\n\n\n\n

The team submitted a regulatory dossier to the ANSM to obtain approval for a Phase I clinical trial and Good Manufacturing Practice (GMP) certification.
The six patients<\/strong> will receive a single intravenous infusion of 1\u00d710\u2076 CAR-T cells per kilogram of body weight, administered 2<\/strong> to 5<\/strong> days after lymphodepleting conditioning with fludarabine at 25 mg\/m\u00b2\/day for 3 days (D-5, -4, -3) and a single dose of cyclophosphamide at 1000 mg\/m\u00b2 on D-3. They will be jointly followed by the hematology team at Gustave Roussy and the Rheumatology team.
The primary safety endpoint will be assessed at 1 <\/strong>month, including cytokine release syndrome, neurologic toxicity, hematologic toxicity, and pseudo-flares in organs previously affected by the autoimmune disease. Efficacy will be evaluated by comparing disease-specific activity scores at 3 <\/strong>and 6 <\/strong>months.<\/p>\n\n\n\n

In parallel, blood sampling, tissue biopsies (e.g., salivary glands), and bone marrow aspirates will enable the assessment of B cell dynamics after CAR-T cell infusion<\/strong>.<\/p>\n\n\n\n

<\/p>\n\n\n\n

\"\"<\/figure>\n","protected":false},"excerpt":{"rendered":"

Academic Development of CD19 CAR T cells Therapy for Refractory Autoimmune Diseases Leaders : Cristina Castilla-Llorente, Camille Bigenwald, Samuel Bitoun, Xavier Mariette Hematologists, Gustave Roussy InstituteRheumatologists, Assistance Publique \u2013 H\u00f4pitaux de Paris, Bic\u00eatre Hospital Synopsis Refractory autoimmune diseases (RAIDs) represent a therapeutic challenge, with limited treatment options. CD19 CAR-T cell immunotherapy, initially developed for hematologic […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":25,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3540","page","type-page","status-publish","hentry"],"yoast_head":"\nCell Attack - FHU CARE\u00b2<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cell Attack - FHU CARE\u00b2\" \/>\n<meta property=\"og:description\" content=\"Academic Development of CD19 CAR T cells Therapy for Refractory Autoimmune Diseases Leaders : Cristina Castilla-Llorente, Camille Bigenwald, Samuel Bitoun, Xavier Mariette Hematologists, Gustave Roussy InstituteRheumatologists, Assistance Publique \u2013 H\u00f4pitaux de Paris, Bic\u00eatre Hospital Synopsis Refractory autoimmune diseases (RAIDs) represent a therapeutic challenge, with limited treatment options. CD19 CAR-T cell immunotherapy, initially developed for hematologic […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/\" \/>\n<meta property=\"og:site_name\" content=\"FHU CARE\u00b2\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-13T12:51:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/fhucare.com\/wp-content\/uploads\/2026\/02\/image-10.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2050\" \/>\n\t<meta property=\"og:image:height\" content=\"1025\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/\",\"url\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/\",\"name\":\"Cell Attack - FHU CARE\u00b2\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/fhucare.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/image-10-1920x960.png\",\"datePublished\":\"2026-01-19T11:59:53+00:00\",\"dateModified\":\"2026-02-13T12:51:37+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/#primaryimage\",\"url\":\"https:\\\/\\\/fhucare.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/image-10-1920x960.png\",\"contentUrl\":\"https:\\\/\\\/fhucare.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/image-10-1920x960.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/cell-attack\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Clinical trials\",\"item\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/clinical-trials\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Cell Attack\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/\",\"name\":\"FHU CARE\u00b2\",\"description\":\"Innovations in Autoimmunity, Cancer & Immunotherapies\",\"publisher\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#organization\"},\"alternateName\":\"CARE2\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#organization\",\"name\":\"FHU CARE\u00b2\",\"alternateName\":\"CARE2\",\"url\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/fhucare.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/CARE2-COULEUR.svg\",\"contentUrl\":\"https:\\\/\\\/fhucare.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/CARE2-COULEUR.svg\",\"caption\":\"FHU CARE\u00b2\"},\"image\":{\"@id\":\"https:\\\/\\\/fhucare.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/in\\\/fhucare\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@fhucare\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Cell Attack - FHU CARE\u00b2","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/","og_locale":"fr_FR","og_type":"article","og_title":"Cell Attack - FHU CARE\u00b2","og_description":"Academic Development of CD19 CAR T cells Therapy for Refractory Autoimmune Diseases Leaders : Cristina Castilla-Llorente, Camille Bigenwald, Samuel Bitoun, Xavier Mariette Hematologists, Gustave Roussy InstituteRheumatologists, Assistance Publique \u2013 H\u00f4pitaux de Paris, Bic\u00eatre Hospital Synopsis Refractory autoimmune diseases (RAIDs) represent a therapeutic challenge, with limited treatment options. CD19 CAR-T cell immunotherapy, initially developed for hematologic […]","og_url":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/","og_site_name":"FHU CARE\u00b2","article_modified_time":"2026-02-13T12:51:37+00:00","og_image":[{"width":2050,"height":1025,"url":"https:\/\/fhucare.com\/wp-content\/uploads\/2026\/02\/image-10.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/","url":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/","name":"Cell Attack - FHU CARE\u00b2","isPartOf":{"@id":"https:\/\/fhucare.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/#primaryimage"},"image":{"@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/#primaryimage"},"thumbnailUrl":"https:\/\/fhucare.com\/wp-content\/uploads\/2026\/02\/image-10-1920x960.png","datePublished":"2026-01-19T11:59:53+00:00","dateModified":"2026-02-13T12:51:37+00:00","breadcrumb":{"@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/#primaryimage","url":"https:\/\/fhucare.com\/wp-content\/uploads\/2026\/02\/image-10-1920x960.png","contentUrl":"https:\/\/fhucare.com\/wp-content\/uploads\/2026\/02\/image-10-1920x960.png"},{"@type":"BreadcrumbList","@id":"https:\/\/fhucare.com\/fr\/clinical-trials\/cell-attack\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/fhucare.com\/fr\/"},{"@type":"ListItem","position":2,"name":"Clinical trials","item":"https:\/\/fhucare.com\/fr\/clinical-trials\/"},{"@type":"ListItem","position":3,"name":"Cell Attack"}]},{"@type":"WebSite","@id":"https:\/\/fhucare.com\/fr\/#website","url":"https:\/\/fhucare.com\/fr\/","name":"FHU CARE\u00b2","description":"Innovations in Autoimmunity, Cancer & Immunotherapies","publisher":{"@id":"https:\/\/fhucare.com\/fr\/#organization"},"alternateName":"CARE2","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/fhucare.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/fhucare.com\/fr\/#organization","name":"FHU CARE\u00b2","alternateName":"CARE2","url":"https:\/\/fhucare.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/fhucare.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/fhucare.com\/wp-content\/uploads\/2025\/11\/CARE2-COULEUR.svg","contentUrl":"https:\/\/fhucare.com\/wp-content\/uploads\/2025\/11\/CARE2-COULEUR.svg","caption":"FHU CARE\u00b2"},"image":{"@id":"https:\/\/fhucare.com\/fr\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/in\/fhucare\/","https:\/\/www.youtube.com\/@fhucare\/"]}]}},"_links":{"self":[{"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/pages\/3540","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/comments?post=3540"}],"version-history":[{"count":3,"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/pages\/3540\/revisions"}],"predecessor-version":[{"id":4284,"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/pages\/3540\/revisions\/4284"}],"up":[{"embeddable":true,"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/pages\/25"}],"wp:attachment":[{"href":"https:\/\/fhucare.com\/fr\/wp-json\/wp\/v2\/media?parent=3540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}