Clinical trial • Phase I • Immunology
CD19-targeted CAR T cells for Myasthenia gravis | Progressive multiple sclerosis | Relapsing multiple sclerosis
Phase I trial of CD19-targeted CAR T cells for Myasthenia gravis | Progressive multiple sclerosis | Relapsing multiple sclerosis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Myasthenia gravis | Progressive multiple sclerosis | Relapsing multiple sclerosis
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 08-12-2023
- First CTIS Authorization Date
- 02-05-2024
Trial design
None/Not specified-controlled Phase I trial across 13 sites in Belgium, France, Germany and others.
- Comparator
- None/Not specified
- Target Sample Size
- 62
- Trial Duration For Participant
- 1781
Recruitment
- Planned Sample Size
- 62
- Recruitment Window Months
- 58
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 56
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 721
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Neurology
- Principal Investigator Name
- Guy Laureys
- Principal Investigator Email
- neurologie.neurochirurgie@uzgent.be
- Contact Person Name
- Guy Laureys
- Contact Person Email
- neurologie.neurochirurgie@uzgent.be
- Site Name
- Antwerp University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Barbara Willekens
- Principal Investigator Email
- neuromusculaire@uza.be
- Contact Person Name
- Barbara Willekens
- Contact Person Email
- neuromusculaire@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 755
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service Maladies du sang
- Principal Investigator Name
- Ibrahim YAKOUB-AGHA
- Principal Investigator Email
- ibrahim.yakoubagha@chu-lille.fr
- Contact Person Name
- Ibrahim YAKOUB-AGHA
- Contact Person Email
- ibrahim.yakoubagha@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Neurologie - CIC Neurosciences
- Principal Investigator Name
- Celine LOUAPRE
- Principal Investigator Email
- celine.louapre@aphp.fr
- Contact Person Name
- Celine LOUAPRE
- Contact Person Email
- celine.louapre@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 21-02-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 750
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Clinical Neuroimmunology
- Principal Investigator Name
- Tania Kuempfel
- Principal Investigator Email
- tania.kuempfel@med.uni-muenchen.de
- Contact Person Name
- Tania Kuempfel
- Contact Person Email
- tania.kuempfel@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Neurology
- Principal Investigator Name
- Refik Pul
- Principal Investigator Email
- refik.pul@uk-essen.de
- Contact Person Name
- Refik Pul
- Contact Person Email
- refik.pul@uk-essen.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Hematology/Oncology
- Principal Investigator Name
- Dimitrios Mougiakakos
- Principal Investigator Email
- dimitrios.mougiakakos@med.ovgu.de
- Contact Person Name
- Dimitrios Mougiakakos
- Contact Person Email
- dimitrios.mougiakakos@med.ovgu.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Neurology
- Principal Investigator Name
- Sven Guenther Meuth
- Principal Investigator Email
- SvenGuenther.Meuth@med.uni-duesseldorf.de
- Contact Person Name
- Sven Guenther Meuth
- Contact Person Email
- SvenGuenther.Meuth@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Silvia Spoerl
- Principal Investigator Email
- silvia.spoerl@uk-erlangen.de
- Contact Person Name
- Silvia Spoerl
- Contact Person Email
- silvia.spoerl@uk-erlangen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 723
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Principal Investigator Name
- Yolanda Blanco
- Principal Investigator Email
- yblanco@clinic.cat
- Contact Person Name
- Yolanda Blanco
- Contact Person Email
- yblanco@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Xavier Montalban
- Principal Investigator Email
- xavier.montalban@cem-cat.org
- Contact Person Name
- Xavier Montalban
- Contact Person Email
- xavier.montalban@cem-cat.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Lucienne Franca
- Principal Investigator Email
- lufrossard@yahoo.es
- Contact Person Name
- Lucienne Franca
- Contact Person Email
- lufrossard@yahoo.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Francisco Carlos Perez Miralles
- Principal Investigator Email
- fcomiralles.neuro@XXX.com
- Contact Person Name
- Francisco Carlos Perez Miralles
- Contact Person Email
- fcomiralles.neuro@XXX.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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