Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
66
Countries
4
Sites
13
Sjogren's Disease
Key facts
- Sponsor
- Cullinan Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 5 Aug 2025 → ongoing
- Decision date (initial)
- 2025-11-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Sjogren's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10040766 | Sjogren's disease | 10028395 |
| 27.1 | PT | 10040767 | Sjogren´s syndrome | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cullinan Therapeutics Inc.
- Sponsor organisation
- Cullinan Therapeutics Inc.
- Address
- 1 Main Street Suite 1350
- City
- Cambridge
- Postcode
- 02142-1531
- Country
- United States
Scientific contact point
- Organisation
- Cullinan Therapeutics Inc.
- Contact name
- Study Responsible Physician
Public contact point
- Organisation
- Cullinan Therapeutics Inc.
- Contact name
- Study Responsible Physician
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 5 |
| Germany | Ongoing, recruiting | 10 | 2 |
| Italy | Authorised, recruiting | 10 | 2 |
| Poland | Authorised, recruitment pending | 10 | 4 |
| Rest of world
United States
|
— | 26 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Service de Rhumatologie, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Les Hopitaux Universitaires De Strasbourg
Service de Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Regional Et Universitaire De Brest
Service de Rhumatologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Nantes
Médecine Interne, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Saint Etienne
Médecine Interne, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 3 – Rheumatologie und Immunologie, Ulmenweg 18, Innenstadt, Erlangen
Medizinische Hochschule Hannover
Klinik für Rheumatologie & Immunologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Rheumatology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Rheumatology, Via Sergio Pansini 5, 80131, Naples
Malopolskie Centrum Kliniczne
MCK, Ul. Balicka 12a/5b, 30-149, Cracow
Biokinetica S.A.
Biokinetica, Ul. Nadwislanska 37, 05-410, Jozefow
Medicover Integrated Clinical Services Sp. z o.o.
MICS, Ul. Chlodna 52, 00-872, Warsaw
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
CWBK, Ul. Spartanska 1, 02-637, Warsaw
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-12-04 | 2025-12-18 | |||
| Germany | 2025-08-05 | 2026-03-10 | |||
| Italy | 2026-01-13 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-25 | Germany | Acceptable 2025-07-04
|
2025-07-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-23 | Germany | Acceptable 2025-07-04
|
2025-07-23 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-09-03 | 2025-11-10 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-09-03 | 2025-11-14 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-18 | Germany | 2025-12-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-12 | Acceptable | 2026-03-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-12 | Germany | Acceptable | 2026-03-04 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-01-23 | Acceptable 2025-07-04
|
2026-04-20 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-26 | Acceptable | 2026-03-06 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-06 | Acceptable | 2026-05-06 |