Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
60
Countries
2
Sites
5
Refractory/relapsed (R/R) CD123-positive acute myeloid leukemia (AML)
Key facts
- Sponsor
- Affimed GmbH, Affimed GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Mar 2023 → 11 Jun 2025
- Decision date (initial)
- 2024-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510021-16-00
- EudraCT number
- 2022-002702-24
- ClinicalTrials.gov
- NCT05817058
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory/relapsed (R/R) CD123-positive acute myeloid leukemia (AML)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Affimed GmbH
- Sponsor organisation
- Affimed GmbH
- Address
- Gottlieb-Daimler-Strasse 2, Oststadt Oststadt
- City
- Mannheim
- Postcode
- 68165
- Country
- Germany
Scientific contact point
- Organisation
- Affimed GmbH
- Contact name
- Lydia Wunderle
Public contact point
- Organisation
- Affimed GmbH
- Contact name
- Elmarie Saenger
Affimed GmbH
- Sponsor organisation
- Affimed GmbH
- Address
- Gottlieb-Daimler-Strasse 2, Oststadt Oststadt
- City
- Mannheim
- Postcode
- 68165
- Country
- Germany
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 25 | 2 |
| Spain | Ended | 35 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Gustave Roussy
Cancer Institute, Clinical Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Oncopole Claudius Regaud
Department of Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Hospital Universitario Y Politecnico La Fe
Hematology Department, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Hematology Department, Avenida De Cordoba Sn, 28041, Madrid
Institut Catala D'oncologia
Clinical Hematology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| France | 2023-06-27 | 2023-09-01 | |||
| Spain | 2023-03-08 | 2023-03-13 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-25 | Spain | Acceptable 2024-10-08
|
2024-10-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-11 | Spain | Acceptable 2025-04-07
|
2025-04-07 |