Clinical trial • Phase III • Immunology|Neurology|Dermatology
CD19-targeted CAR iNK cells for Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous systemic sclerosis
Phase III trial of CD19-targeted CAR iNK cells for Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous s…
Overview
- Trial Therapeutic Area
- Immunology|Neurology|Dermatology
- Trial Disease
- Systemic lupus erythematosus | Lupus nephritis | Idiopathic inflammatory myopathy | Diffuse cutaneous systemic sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 06-12-2024
- First CTIS Authorization Date
- 16-04-2025
Trial design
None/Not specified-controlled Phase III trial across 6 sites in France, Germany, Italy.
- Comparator
- None/Not specified
- Target Sample Size
- 24
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 9
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 16
France
- Latest Decision Or Authorization Date
- 21-11-2025
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- 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
- 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
Germany
- Latest Decision Or Authorization Date
- 19-12-2025
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Johannes Wesling Klinikum Minden
- Department Name
- Department of rheumatologyand 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
- Latest Decision Or Authorization Date
- 17-11-2025
- Number Of Sites
- 2
- Number Of Participants
- 4
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
- Hematology and Cell Therapy
- Principal Investigator Name
- Emanuele Angelucci
- Principal Investigator Email
- Emanuele.angelucci@hsanmartino.it
- Contact Person Name
- Emanuele Angelucci
- Contact Person Email
- Emanuele.angelucci@hsanmartino.it
Sponsor
Primary sponsor
- Full Name
- Century Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CNTY-101
- Active Substance
- CD19-targeted CAR iNK cells
- Modality
- Cell therapy
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