Clinical trial • Phase I|Phase III • Immunology
CLN-978 for Sjögren's syndrome
Phase I|Phase III trial of CLN-978 for Sjögren's syndrome. open-label. 26 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Sjögren's syndrome
- Trial Stage
- Phase I|Phase III
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 04-07-2025
Trial design
open-label Phase I|Phase III trial in Germany, France, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 26
Recruitment
- Planned Sample Size
- 26
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 40
Germany
- Earliest CTIS Part Ii Submission Date
- 20-06-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 257
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Rheumatologie & Immunologie
- Contact Person Name
- Torsten Witte
- Contact Person Email
- rheumatologie@mh-hannover.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 3 – Rheumatologie und Immunologie
- Contact Person Name
- Ricardo Grieshaber-Bouyer
- Contact Person Email
- ricardo.grieshaber@uk-erlangen.de
France
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 131
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Rhumatologie
- Contact Person Name
- Divi Cornec
- Contact Person Email
- divi.cornec@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Médecine Interne
- Contact Person Name
- Antoine Néel
- Contact Person Email
- antoine.neel@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Médecine Interne
- Contact Person Name
- Martin Killian
- Contact Person Email
- martin.killian@chu-st-etienne.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Rhumatologie
- Contact Person Name
- Jacques-Eric Gottenberg
- Contact Person Email
- jacques-eric.gottenberg@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Rhumatologie
- Contact Person Name
- Xavier Mariette
- Contact Person Email
- Xavier.mariette@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 150
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Rheumatology
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Rheumatology
- Contact Person Name
- Francesco Ciccia
- Contact Person Email
- francesco.ciccia@unicampania.it
Poland
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 34
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS
- Contact Person Name
- Małgorzata Gryka-Marton
- Contact Person Email
- marta.jeka@medicover.com
- Site Name
- Biokinetica S.A.
- Department Name
- Biokinetica
- Contact Person Name
- Małgorzata Gryka-Marton
- Contact Person Email
- office@biokinetica.com
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- CWBK
- Contact Person Name
- Brygida Kwiatkowska
- Contact Person Email
- cwbk@spartanska.pl
- Site Name
- Malopolskie Centrum Kliniczne
- Department Name
- MCK
- Contact Person Name
- Ewa Zimmer-Satora
- Contact Person Email
- biuro@mck-krakow.pl
Sponsor
Primary sponsor
- Full Name
- Cullinan Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CLN-978
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