Clinical trial • Phase I • Immunology
CD19-targeted CAR T cells for Systemic sclerosis | Rheumatoid arthritis | Idiopathic inflammatory myopathy | Systemic lupus erythematosus
Phase I trial of CD19-targeted CAR T cells for Systemic sclerosis | Rheumatoid arthritis | Idiopathic inflammatory myopathy | Systemic lupus erythematosus.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic sclerosis | Rheumatoid arthritis | Idiopathic inflammatory myopathy | Systemic lupus erythematosus
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 30-11-2023
- First CTIS Authorization Date
- 09-04-2024
Trial design
None/Not specified-controlled Phase I trial across 22 sites in France, Italy, Belgium and others.
- Comparator
- None/Not specified
- Target Sample Size
- 144
Recruitment
- Planned Sample Size
- 144
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 126
France
- Earliest CTIS Part Ii Submission Date
- 18-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 835
- Number Of Sites
- 7
- Number Of Participants
- 31
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Rhumatologie
- Contact Person Name
- Marc Scherlinger
- Contact Person Email
- marc.scherlinger@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Unité de Médecine Interne (UF 04) : CRMR MATHEC
- Contact Person Name
- Dominique FARGE
- Contact Person Email
- dominique.farge-bancel@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hématologie clinique et thérapie cellulaire
- Contact Person Name
- Edouard Forcade
- Contact Person Email
- edouard.forcade@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Unité Immuno-rhumatologie
- Contact Person Name
- Jacques MOREL
- Contact Person Email
- j-morel@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- département d'hématologie
- Contact Person Name
- Roch HOUOT
- Contact Person Email
- roch.houot@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Immunologie Clinique
- Contact Person Name
- Nihal Martis
- Contact Person Email
- martis.n@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- service maladie du sang
- Contact Person Name
- Ibrahim YAKOUB-AGHA
- Contact Person Email
- ibrahim.yakoubagha@chru-lille.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 18-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 835
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Humanitas Research Hospital
- Department Name
- Oncology and Haematology
- Contact Person Name
- Armando Santoro
- Contact Person Email
- xxx@xxx
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Rheumatology
- Contact Person Name
- Maria Antonietta D'Agostino
- Contact Person Email
- xxx@xxx
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 835
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- UZ Leuven
- Department Name
- Rheumatology
- Contact Person Name
- Ellen de Langhe
- Contact Person Email
- reumatologie@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 772
- Number Of Sites
- 7
- Number Of Participants
- 57
Sites
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Rheumatologie
- Contact Person Name
- Joerg Distler
- Contact Person Email
- joerg.distler@med.uni-duesseldorf.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Innere Medizin I
- Contact Person Name
- Philipp Koehler
- Contact Person Email
- philipp.koehler@uk-koeln.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
- Contact Person Name
- David Simon
- Contact Person Email
- david.simon@charite.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik Poliklinik II, Zentrum für Innere Medizin
- Contact Person Name
- Marc Schmalzing
- Contact Person Email
- schmalzing_m@ukw.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 3 (M3)
- Contact Person Name
- Georg Schett
- Contact Person Email
- Georg.Schett@uk-erlangen.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Universitätsklinik für Hämatologie, Onkologie und Zelltherapie
- Contact Person Name
- Dimitrios Mougiakakos
- Contact Person Email
- dimitrios.mougiakakos@med.ovgu.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
- Contact Person Name
- Vladan Vucinic
- Contact Person Email
- vladan.vucinic@medizin.uni-leipzig.de
Spain
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 749
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Rheumatology
- Contact Person Name
- Josefina Cortes-Hernandez
- Contact Person Email
- fina.cortes@vhir.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Rheumatology
- Contact Person Name
- Ricardo Blanco
- Contact Person Email
- ricardo.blanco@scsalud.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Rheumatology
- Contact Person Name
- Ignasi Rodriguez-Pintó
- Contact Person Email
- irodrip@clinic.cat
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Rheumatology
- Contact Person Name
- Alejandro Escudero
- Contact Person Email
- alexcudero@hotmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- Contact Person Name
- Antonio Fernandez Nebro
- Contact Person Email
- afnebro@gmail.com
Sponsor
Primary sponsor
- Full Name
- Celgene Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CD19-targeted NEX-T CAR T Cells
- Active Substance
- CD19-targeted CAR T cells
- Modality
- Cell therapy
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