Clinical trial • Phase I • Immunology
CD19-targeted CAR T cells for Idiopathic Inflammatory Myopathy | Systemic Lupus Erythematosus | Rheumatoid Arthritis | Systemic Sclerosis
Phase I trial of CD19-targeted CAR T cells for Idiopathic Inflammatory Myopathy | Systemic Lupus Erythematosus | Rheumatoid Arthritis | Systemic Sclerosis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Idiopathic Inflammatory Myopathy | Systemic Lupus Erythematosus | Rheumatoid Arthritis | Systemic Sclerosis
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 21-02-2025
- First CTIS Authorization Date
- 16-07-2025
Trial design
Phase I trial across 18 sites in Spain, Germany, Poland and others.
- Target Sample Size
- 40
Eligibility
Recruits 40 No vulnerable populations selected (isVulnerablePopulationSelected = false). Consent/assent handling not specified in the provided record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected = false). Consent/assent handling not specified in the provided record.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 42
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 93
Spain
- Earliest CTIS Part Ii Submission Date
- 13-05-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 70
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Reumatologia
- Principal Investigator Name
- Maria Jesus Garcia Villanueva
- Principal Investigator Email
- xxx@xxx.com
- Contact Person Name
- Maria Jesus Garcia Villanueva
- Contact Person Email
- xxx@xxx.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Reumatologia
- Principal Investigator Name
- Alfredo Guillen del Castillo
- Principal Investigator Email
- alfredo.guillen@vallhebron.cat
- Contact Person Name
- Alfredo Guillen del Castillo
- Contact Person Email
- alfredo.guillen@vallhebron.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Reumatologia
- Principal Investigator Name
- Ivan Castellvi
- Principal Investigator Email
- icastellvi@santpau.cat
- Contact Person Name
- Ivan Castellvi
- Contact Person Email
- icastellvi@santpau.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 65
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik III, Abteilung für Rheumatologie
- Principal Investigator Name
- Anne- Kathrin Tausche- Wunderlich
- Principal Investigator Email
- anne-kathrin.tausche@ukdd.de
- Contact Person Name
- Anne- Kathrin Tausche- Wunderlich
- Contact Person Email
- anne-kathrin.tausche@ukdd.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Zentrum für Innere Medizin, III. Medizinische Klinik und Poliklinik (Nephr./Rheum./Endokr.)
- Principal Investigator Name
- Martin Krusche
- Principal Investigator Email
- m.krusche@uke.de
- Contact Person Name
- Martin Krusche
- Contact Person Email
- m.krusche@uke.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Innere Medizin, Haematologie und Onkologie
- Principal Investigator Name
- Catrin Meyer
- Principal Investigator Email
- catrin.meyer@uksh.de
- Contact Person Name
- Catrin Meyer
- Contact Person Email
- catrin.meyer@uksh.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Rheumatologie
- Principal Investigator Name
- Jörg Distler
- Principal Investigator Email
- joerg.distler@med.uni-duesseldorf.de
- Contact Person Name
- Jörg Distler
- Contact Person Email
- joerg.distler@med.uni-duesseldorf.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Rheumatologie, Immunologie
- Principal Investigator Name
- David Simon
- Principal Investigator Email
- david.simon@charite.de
- Contact Person Name
- David Simon
- Contact Person Email
- david.simon@charite.de
Poland
- Earliest CTIS Part Ii Submission Date
- 13-05-2025
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 71
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Osrodek Badan Klinicznych Wczesnych Faz
- Principal Investigator Name
- Anna Wojteczek
- Principal Investigator Email
- a.wojteczek@gumend.edu.pl
- Contact Person Name
- Anna Wojteczek
- Contact Person Email
- a.wojteczek@gumend.edu.pl
- Site Name
- Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
- Department Name
- Oddzial Reumatologii i Rehabilitacji
- Principal Investigator Name
- Aleksandra Zon-Giebel
- Principal Investigator Email
- sreumatologia@szpital1.bytom.pl
- Contact Person Name
- Aleksandra Zon-Giebel
- Contact Person Email
- sreumatologia@szpital1.bytom.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddzial Reumatologii i Ukladowych Chorob Tkanki Lacznej
- Principal Investigator Name
- Adam Fronczak
- Principal Investigator Email
- adamum@op.pl
- Contact Person Name
- Adam Fronczak
- Contact Person Email
- adamum@op.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Transplantacji Szpiku i Onkohematologii
- Principal Investigator Name
- Sebastian Giebel
- Principal Investigator Email
- sebastian.giebel@io.gliwice.pl
- Contact Person Name
- Sebastian Giebel
- Contact Person Email
- sebastian.giebel@io.gliwice.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 20-05-2025
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 65
- Number Of Sites
- 2
- Number Of Participants
- 26
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Phase1Unit AEM in colab with Fundeni Clinical Institute Dep IV Hematology Bone Marrow Transplantat
- Principal Investigator Name
- Mihai Abobului
- Principal Investigator Email
- abc@yahoo.com
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- abc@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Phase 1 Unit AEM in collab with IOCN, Radiotherapy departament
- Principal Investigator Name
- Ciprian Tomuleasa
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Ciprian Tomuleasa
- Contact Person Email
- office@iocn.ro
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 30-07-2025
- Processing Time Days
- 75
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Oddeleni revmatologie deti a dospelych
- Principal Investigator Name
- Rudolf Horvath
- Principal Investigator Email
- rudolf.horvath@fnmotol.cz
- Contact Person Name
- Rudolf Horvath
- Contact Person Email
- rudolf.horvath@fnmotol.cz
- Site Name
- Revmatologicky Ustav
- Principal Investigator Name
- Ladislav Senolt
- Principal Investigator Email
- senolt@revma.cz
- Contact Person Name
- Ladislav Senolt
- Contact Person Email
- senolt@revma.cz
France
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 186
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Rhumatologie
- Principal Investigator Name
- Marc SCHERLINGER
- Principal Investigator Email
- marc.scherlinger@chru-strasbourg.fr
- Contact Person Name
- Marc SCHERLINGER
- Contact Person Email
- marc.scherlinger@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Maladie 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
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Investigational products
- Investigational Product Name
- Healthy Donor CD19-targeted Allogeneic CAR T Cells
- Active Substance
- CD19-targeted CAR T cells
- Modality
- Cell therapy
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