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
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

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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