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

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
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Rhumatologie
Contact Person Name
Jacques-Eric Gottenberg
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
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Rheumatology
Contact Person Name
Francesco Ciccia

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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