Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
71
Countries
3
Sites
6
Myelofibrosis
Key facts
- Sponsor
- Ajax Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 26 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522033-64-00
- WHO UTN
- U1111-1322-0018
- ClinicalTrials.gov
- NCT06343805
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myelofibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ajax Therapeutics Inc.
- Sponsor organisation
- Ajax Therapeutics Inc.
- Address
- 275 Madison Avenue Floor 39th
- City
- New York
- Postcode
- 10016-1132
- Country
- United States
Scientific contact point
- Organisation
- Ajax Therapeutics Inc.
- Contact name
- David Steensma
Public contact point
- Organisation
- Ajax Therapeutics Inc.
- Contact name
- Martin Vogelbaum
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 4 | 1 |
| Italy | Authorised, recruitment pending | 7 | 2 |
| Spain | Ongoing, recruiting | 9 | 3 |
| Rest of world
United States
|
— | 51 | — |
Investigational sites
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 | 2026-02-26 | 2026-06-01 | |||
| Spain | 2026-03-05 | 2026-03-26 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-01 | Spain | Acceptable 2026-02-09
|
2026-02-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-19 | Acceptable 2026-02-09
|
2026-02-19 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-20 | 2026-02-20 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-20 | Spain | Acceptable | 2026-03-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-06 | Spain | Acceptable | 2026-03-06 |