Clinical trial • Phase III • Immunology|Dermatology|Neurology|Oncology
Clinical trial in Hematological malignancies|Solid tumor malignancies|Autoimmune diseases|Non-Hodgkin lymphoma|Systemic lupus erythematosus|Lupus nephritis|Diffuse systemic sclerosis|Idiopathic inflammatory myopathy
Phase III trial for Hematological malignancies|Solid tumor malignancies|Autoimmune diseases|Non-Hodgkin lymphoma|Systemic lupus erythematosus|Lupus nephri…
Overview
- Trial Therapeutic Area
- Immunology|Dermatology|Neurology|Oncology
- Trial Disease
- Hematological malignancies|Solid tumor malignancies|Autoimmune diseases|Non-Hodgkin lymphoma|Systemic lupus erythematosus|Lupus nephritis|Diffuse systemic sclerosis|Idiopathic inflammatory myopathy
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 28-03-2025
- First CTIS Authorization Date
- 22-07-2025
Trial design
Phase III trial across 6 sites in France, Germany, Italy.
- Target Sample Size
- 48
Eligibility
Recruits 48 Vulnerable population(s) selected in CTIS; no details available on consent or assent handling in the provided data..
- Vulnerable Population
- Vulnerable population(s) selected in CTIS; no details available on consent or assent handling in the provided data.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 81
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 15
France
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Département de médecine interne
- Principal Investigator Name
- Gregory Pugnet
- Principal Investigator Email
- pugnet.g@chu-toulouse.fr
- Contact Person Name
- Gregory Pugnet
- Contact Person Email
- pugnet.g@chu-toulouse.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Alain Meyer
- Principal Investigator Email
- alain.meyer1@chru-strasbourg.fr
- Contact Person Name
- Alain Meyer
- Contact Person Email
- alain.meyer1@chru-strasbourg.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service d’Immunologie Clinique
- Principal Investigator Name
- Alain Meyer
- Principal Investigator Email
- alain.meyer1@chru-strasbourg.fr
- Contact Person Name
- Alain Meyer
- Contact Person Email
- alain.meyer1@chru-strasbourg.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-06-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 35
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Johannes Wesling Klinikum Minden
- Department Name
- Department of rheumatology and clinical immunology
- Principal Investigator Name
- Gunter Aßmann
- Principal Investigator Email
- gunter.assmann@muehlenkreiskliniken.de
- Contact Person Name
- Gunter Aßmann
- Contact Person Email
- gunter.assmann@muehlenkreiskliniken.de
Italy
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 83
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Rheumatology
- Principal Investigator Name
- Maria Antonietta D’Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Hematologyand Cell Therapy
- Principal Investigator Name
- Massimiliano Gambella
- Principal Investigator Email
- massimiliano.gambella@hsanmartino.it
- Contact Person Name
- Massimiliano Gambella
- Contact Person Email
- massimiliano.gambella@hsanmartino.it
Sponsor
Primary sponsor
- Full Name
- Century Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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