Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
63
Countries
3
Sites
6
Hematological or solid tumor malignancies or autoimmune diseases
Key facts
- Sponsor
- Century Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Mar 2026 → ongoing
- Decision date (initial)
- 2025-07-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520222-11-00
- ClinicalTrials.gov
- NCT05768269
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hematological or solid tumor malignancies or autoimmune diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
| 22.0 | PT | 10029547 | Non-Hodgkin's lymphoma | 100000004864 |
| 21.0 | LLT | 10012977 | Diffuse systemic sclerosis | 10028395 |
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Century Therapeutics Inc.
- Sponsor organisation
- Century Therapeutics Inc.
- Address
- 25 North 38th Street Fl 11
- City
- Philadelphia
- Postcode
- 19104-5640
- Country
- United States
Scientific contact point
- Organisation
- Century Therapeutics Inc.
- Contact name
- Century Therapeutics Clinical Team
Public contact point
- Organisation
- Century Therapeutics Inc.
- Contact name
- Century Therapeutics Clinical Team
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 4 | 3 |
| Germany | Authorised, recruiting | 8 | 1 |
| Italy | Ended | 3 | 2 |
| Rest of world
United States
|
— | 48 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Département de médecine interne, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Les Hopitaux Universitaires De Strasbourg
Service d’Immunologie Clinique, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Les Hopitaux Universitaires De Strasbourg
Service de Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Johannes Wesling Klinikum Minden
Department of rheumatology and clinical immunology, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
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 | 2026-03-03 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Germany | Acceptable 2025-07-21
|
2025-07-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-06 | Acceptable | 2025-09-24 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | Germany | Acceptable | 2025-12-19 |