{"id":3540,"date":"2026-01-19T12:59:53","date_gmt":"2026-01-19T11:59:53","guid":{"rendered":"https:\/\/fhucare2.laurent-angeli.fr\/?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:\/\/fhucare2.laurent-angeli.fr\/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"],"_links":{"self":[{"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/pages\/3540","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/comments?post=3540"}],"version-history":[{"count":3,"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/pages\/3540\/revisions"}],"predecessor-version":[{"id":4284,"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/pages\/3540\/revisions\/4284"}],"up":[{"embeddable":true,"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/pages\/25"}],"wp:attachment":[{"href":"https:\/\/fhucare2.laurent-angeli.fr\/fr\/wp-json\/wp\/v2\/media?parent=3540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}