Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
25
Countries
1
Sites
3
Relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Key facts
- Sponsor
- Catapult Therapeutics B.V.
- 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
- 23 Aug 2021 → ongoing
- Decision date (initial)
- 2024-08-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516341-39-00
- EudraCT number
- 2022-000759-35
- ClinicalTrials.gov
- NCT04704323
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10068919 | B-cell chronic lymphocytic leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Catapult Therapeutics B.V.
- Sponsor organisation
- Catapult Therapeutics B.V.
- Address
- Zuidersluisweg 2
- City
- Lelystad
- Postcode
- 8243 RC
- Country
- Netherlands
Scientific contact point
- Organisation
- Catapult Therapeutics B.V.
- Contact name
- Fernando Terrón Fernández
Public contact point
- Organisation
- Catapult Therapeutics B.V.
- Contact name
- Fernando Terrón Fernández
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 11 | 3 |
| Rest of world
United States
|
— | 14 | — |
Investigational sites
Hospital Universitario De La Princesa
Hematology, Calle De Diego De Leon 62, 28006, Madrid
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
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 |
|---|---|---|---|---|---|
| Spain | 2021-08-23 | 2021-11-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Spain | Acceptable with conditions 2024-08-27
|
2024-08-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-11 | Spain | Acceptable with conditions 2024-08-27
|
2026-05-11 |