Clinical trial • Phase I • Oncology|Haematology
AJ1-11095 (AJX-101) for Myelofibrosis
Phase I trial of AJ1-11095 (AJX-101) for Myelofibrosis. 51 participants.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Myelofibrosis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 01-10-2025
- First CTIS Authorization Date
- 09-02-2026
Trial design
Phase I trial across 6 sites in France, Italy, Spain.
- Target Sample Size
- 51
- Trial Duration For Participant
- 427
Eligibility
Recruits 51 Vulnerable population selected; no further details on consent or assent provided in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent provided in the record.
Recruitment
- Planned Sample Size
- 51
- Recruitment Window Months
- 14
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 20
France
- Earliest CTIS Part Ii Submission Date
- 03-12-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 68
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Hopital Saint Louis
- Department Name
- Clinical Investigation Center
- Contact Person Name
- Jean-Jacques Kiladjian
- Contact Person Email
- jean-jacques.kiladjian@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Hematology
- Contact Person Name
- Francesco Passamonti
- Contact Person Email
- francesco.passamonti@policlinico.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Hematology
- Contact Person Name
- Francesca Palandri
- Contact Person Email
- francesca.palandri@unibo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Contact Person Name
- Valentín García Gutiérrez
- Contact Person Email
- jvalentingg@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Contact Person Name
- Ana Triguero Moreno
- Contact Person Email
- atriguero@clinic.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematology
- Contact Person Name
- Santiago Osorio Prendes
- Contact Person Email
- santiago.osorio@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Ajax Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AJ1-11095 (AJX-101)
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