Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
6
Countries
1
Sites
1
Patients with hematological malignancies (Cf. inclusion criteria) HLA-DPB1*04:01 positive allografted with a geno- or pheno- or haplo-identical donor or cord blood HLA-DPB1*04:01 negative
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 9 Feb 2020 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515504-39-00
- EudraCT number
- 2016-004667-38
- ClinicalTrials.gov
- NCT04180059
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with hematological malignancies (Cf. inclusion criteria) HLA-DPB1*04:01 positive allografted with a geno- or pheno- or haplo-identical donor or cord blood HLA-DPB1*04:01 negative
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Thierry GUILLAUME
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Dr Thierry GUILLAUME
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2020-02-09 | 2020-02-09 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | France | Acceptable 2024-08-30
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-28 | France | Acceptable 2025-08-19
|
2025-09-12 |