Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
2
Relapsed/refractory (R/R) diffuse large B-cell lymphoma
Key facts
- Sponsor
- Emercell SAS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2025-02-04
- 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
Relapsed/refractory (R/R) diffuse large B-cell lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012821 | Diffuse large B-cell lymphoma recurrent | 100000004864 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Emercell SAS
- Sponsor organisation
- Emercell SAS
- Address
- 36 Chemin De L Hopital
- City
- Saint-Mathieu-De-Treviers
- Postcode
- 34270
- Country
- France
Scientific contact point
- Organisation
- Emercell SAS
- Contact name
- Alain Herrera
Public contact point
- Organisation
- Emercell SAS
- Contact name
- Alain Herrera
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 10 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
CHU de Montpellier
Clinical Hematology Department, 39 Avenue Charles Flahaut, 34295, Montpellier Cedex 05
Oncopole Claudius Regaud
Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-25 | France | Acceptable 2025-02-04
|
2025-02-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | France | Acceptable 2025-04-14
|
2025-04-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-04 | France | Acceptable | 2025-07-15 |