Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
46
Countries
3
Sites
10
Treatment-Refractory Rheumatoid Arthritis
Key facts
- Sponsor
- Cullinan Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 15 May 2025 → ongoing
- Decision date (initial)
- 2025-04-11
- 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
Treatment-Refractory Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 2 |
| Italy | Ongoing, recruiting | 20 | 3 |
| Poland | Authorised, recruitment pending | 6 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Klinik für Hämatologie, Onkologie und Rheumatologie Innere Medizin V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 3 – Rheumatologie und Immunologie, Ulmenweg 18, Innenstadt, Erlangen
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Rheumatology, Largo Francesco Vito 1, 00168, Rome
Humanitas Mirasole S.p.A.
Division of Rheumatology and Clinical Immunology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Rheumatology, Via Sergio Pansini 5, 80131, Naples
Biokinetica S.A.
CWBK, Ul. Nadwislanska 37, 05-410, Jozefow
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
CWBK, Ul. Spartanska 1, 02-637, Warsaw
Malopolskie Centrum Kliniczne
CWBK, Ul. Balicka 12a/5b, 30-149, Cracow
Medicover Integrated Clinical Services Sp. z o.o.
NA, Ul. Chlodna 52, 00-872, Warsaw
Med Polonia Sp. z o.o.
NA, Obornicka 262, 60-693, Poznan
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 |
|---|---|---|---|---|---|
| Germany | 2025-05-15 | 2025-05-19 | |||
| Italy | 2025-06-13 | 2025-09-02 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Germany | Acceptable 2025-04-11
|
2025-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-28 | Germany | Acceptable 2025-06-17
|
2025-06-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-27 | Germany | Acceptable 2025-06-17
|
2025-06-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-02 | Germany | Acceptable | 2025-07-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-08 | Germany | Acceptable | 2025-09-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-11 | Germany | Acceptable 2026-01-26
|
2026-01-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-11 | Germany | Acceptable 2026-01-26
|
2026-02-11 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-02-13 | Acceptable 2026-01-26
|
2026-05-06 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-19 | Germany | Acceptable | 2026-03-25 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-03 | |||
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-04 | Acceptable | 2026-04-20 |