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A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

NCT06343805 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-12

No results posted yet for this study

Summary

AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.

Conditions

  • Primary Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • PMF
  • PPV-MF
  • PET-MF

Interventions

DRUG

AJ1-11095

Type II JAK2 Inhibitor

Sponsors & Collaborators

  • Ajax Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • John Mascarenhas, M.D. · Mt. Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2026-10-15
Completion
2027-02-15
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343805 on ClinicalTrials.gov