Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
4
Malignant B-cell neoplasms
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-04-22
- 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
Malignant B-cell neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
| 28.0 | LLT | 10084346 | B-cell non-Hodgkin´s lymphoma | 100000004848 |
| 20.1 | LLT | 10076867 | Acute lymphocytic leukemia refractory | 10029104 |
| 28.1 | LLT | 10000848 | Acute lymphocytic leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Sponsor organisation
- Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Address
- Avda De Cordoba, Centro De Actividades Ambulatorias 6a Planta Bloque D Centro De Actividades Ambulatorias 6a Planta Bloque D
- City
- Madrid
- Postcode
- 28041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Contact name
- Dra. María Liz Paciello Coronel
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre
- Contact name
- Dra. María Liz Paciello Coronel
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 24 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Germans Trias I Pujol
Haematology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario 12 De Octubre
Haematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinic De Barcelona
Haematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Y Politecnico La Fe
Haematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-31 | Spain | Acceptable with conditions 2026-04-20
|
2026-04-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-04 | Spain | Acceptable 2026-05-21
|
2026-05-22 |