Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
50
Countries
1
Sites
5
CD123 positive R/R AML and intermediate risk, high risk, or extremely high risk MDS.
Key facts
- Sponsor
- LAVA Therapeutics N.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Apr 2025 → 5 Aug 2025
- Decision date (initial)
- 2025-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
CD123 positive R/R AML and intermediate risk, high risk, or extremely high risk MDS.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
LAVA Therapeutics N.V.
- Sponsor organisation
- LAVA Therapeutics N.V.
- Address
- Yalelaan 62
- City
- Utrecht
- Postcode
- 3584 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- LAVA Therapeutics N.V.
- Contact name
- Clinical Trials administrator
Public contact point
- Organisation
- LAVA Therapeutics N.V.
- Contact name
- Clinical Trials administrator
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 20 | 5 |
| Rest of world
Australia
|
— | 30 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
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 | 2025-04-15 | 2025-04-25 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-29 | Spain | Acceptable 2025-03-14
|
2025-03-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-02 | Spain | Acceptable 2025-03-14
|
2025-04-02 |