Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
40
Countries
2
Sites
6
Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome
Key facts
- Sponsor
- Genmab A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-16
- 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 or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10088023 | Myelodysplastic syndrome with excess blasts | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genmab A/S
- Sponsor organisation
- Genmab A/S
- Address
- Carl Jacobsens Vej 30
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- Genmab A/S
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Genmab A/S
- Contact name
- Clinical Trial Information
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 16 | 2 |
| Spain | Ongoing, recruiting | 24 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Department of Haemotology, Blegdamsvej 9, 2100, Copenhagen Oe
Hospital Universitari Vall D Hebron
Haematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Haematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Haematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinic De Barcelona
Haematology, Calle Villarroel 170, 08036, Barcelona
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 |
|---|---|---|---|---|---|
| Denmark | 2026-02-16 | 2026-02-16 | |||
| Spain | 2026-05-07 | 2026-05-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-12 | Denmark | Acceptable 2026-01-09
|
2026-01-16 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2026-02-03 | Acceptable 2026-01-09
|
2026-03-11 |