Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
61
Countries
1
Sites
5
Patients with Relapsed/Refractory Acute Myeloid Leukemia or High/Very-high Risk Myelodysplastic Syndromes, Ineligible for Intensiveor New Generation Targeted Therapy
Key facts
- Sponsor
- Advanced Biodesign
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518813-24-00
- EudraCT number
- 2021-003159-41
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with Relapsed/Refractory Acute Myeloid Leukemia or High/Very-high Risk Myelodysplastic Syndromes, Ineligible for Intensiveor New Generation Targeted Therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081514 | Acute myeloid leukemia refractory | 10029104 |
| 20.0 | HLT | 10028536 | Myelodysplastic syndromes | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Advanced Biodesign
- Sponsor organisation
- Advanced Biodesign
- Address
- 575/655 Allee Des Parcs
- City
- St Priest
- Postcode
- 69800
- Country
- France
Scientific contact point
- Organisation
- Advanced Biodesign
- Contact name
- Guillaume MARTIN
Public contact point
- Organisation
- Advanced Biodesign
- Contact name
- Guillaume MARTIN
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 61 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nice
Clinical hematologie, 151 Route De Saint Antoine, 06200, Nice
Hopital Saint Louis
INSERM CIC 1427 - INSERM U944, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional De Marseille
CEPCM, 144 Rue Saint Pierre, 13005, Marseille
Hospices Civils De Lyon
Clinical Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Montpellier
clinical hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
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 | 2024-11-12 | 2024-11-12 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | France | Acceptable 2024-11-12
|
2024-11-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-19 | France | Acceptable with conditions 2025-06-05
|
2025-06-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-23 | France | Acceptable 2025-07-08
|
2025-07-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-10 | France | Acceptable 2025-07-08
|
2025-11-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-05 | France | Acceptable 2026-03-18
|
2026-03-18 |