Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
75
Countries
3
Sites
13
B-Cell Non-Hodgkin’s Lymphoma (B-NHL)
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 19 Apr 2024 → 30 Apr 2026
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508209-25-00
- EudraCT number
- 2015-001697-17
- ClinicalTrials.gov
- NCT02651662
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-Cell Non-Hodgkin’s Lymphoma (B-NHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086815 | B-cell non-Hodgkin´s lymphoma recurrent | 100000004848 |
| 25.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
3 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 2 |
| Poland | Ended | 9 | 1 |
| Spain | Ended | 45 | 10 |
| Rest of world
Israel, United States
|
— | 17 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
N/A, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Department of Medicine I, Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Austria | 2024-11-18 | 2024-11-18 | |||
| Poland | 2024-09-09 | 2026-04-29 | 2024-09-09 | 2025-07-09 | |
| Spain | 2024-04-19 | 2026-04-07 | 2024-04-19 | 2025-07-09 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-06 | Spain | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-04-24 | Acceptable 2024-03-25
|
2024-07-22 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-04-25 | Acceptable 2024-03-25
|
2024-07-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-17 | Spain | Acceptable with conditions 2024-12-16
|
2024-12-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-09 | Spain | Acceptable 2025-07-03
|
2025-07-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-07 | Spain | Acceptable 2025-11-24
|
2025-11-26 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-30 | Spain | Acceptable 2025-11-24
|
2026-01-30 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-23 | Acceptable 2025-11-24
|
2026-04-23 |