Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
72
Countries
6
Sites
11
Systemic Lupus Erythematosus
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
- 10 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518780-36-00
- ClinicalTrials.gov
- NCT06613360
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 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
6 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 8 | 1 |
| France | Authorised, recruiting | 4 | 3 |
| Germany | Authorised, recruitment pending | 10 | 1 |
| Poland | Authorised, recruitment pending | 6 | 3 |
| Romania | Ongoing, recruiting | 12 | 2 |
| Spain | Authorised, recruitment pending | 4 | 1 |
| Rest of world
United States, Moldova, Republic of, Georgia, Australia
|
— | 28 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
Internal Diseases, Bulevard Bilgariya 104, 1404, Sofiya
Centre Hospitalier Universitaire De Toulouse
Service Medecine Interne et immunologie clinique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
Service Medecine Interne, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Saint Etienne
Service Medecine Interne, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V/ Sektion Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Nie dotyczy, Ul. Spartanska 1, 02-637, Warsaw
Malopolskie Centrum Kliniczne
Nie dotyczy, Ul. Balicka 12a/5b, 30-149, Cracow
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Chłodna, Ul. Chlodna 52, 00-872, Warsaw
Arensia Clinics S.R.L.
3rd Floor, Wards 1, 2, 3, 4, 5, 6 and 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, Strada Clinicilor 3-5, 400006, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-12-10 | 2025-12-17 | |||
| France | 2026-05-06 | ||||
| Romania | 2026-03-19 | 2026-03-26 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-15 | Bulgaria | Acceptable 2025-11-24
|
2025-11-25 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2025-12-05 | 2026-03-16 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-01-19 | Acceptable 2025-11-24
|
2026-04-10 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-01-19 | Acceptable 2025-11-24
|
2026-04-08 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2026-01-28 | Acceptable 2025-11-24
|
2026-04-01 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2026-02-02 | Acceptable 2025-11-24
|
2026-04-29 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Bulgaria | Acceptable 2025-11-24
|
2026-05-06 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-06 | Bulgaria | Acceptable 2025-11-24
|
2026-05-06 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-08 | Acceptable 2025-11-24
|
2026-05-08 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-20 | Acceptable 2025-11-24
|
2026-05-20 |