NCT06343805 · Ajax Therapeutics, Inc.
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)
What this study is about
AJX-101 is a first-in-human (FIH), phase 1, non-randomly assigned, multi-center, where both patients and doctors know the treatment given clinical trial designed to investigate the safety, tolerability, how the drug moves through the body (PK), clinical activity and changes in biomarkers of an taken by mouth administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years of age or older.
- Diagnosis of PMF, post-PV MF, or post-ET MF.
- DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.
- Estimated spleen volume ≥450cm3.
- MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.
- ECOG PS of 0, 1, 2, or 3.
- Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.
- ANC ≥1.0×10\^9/L.
- Platelet count ≥75×10\^9/L.
- eGFR ≥45 mL/min/1.73m2.
- Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
- AST and ALT ≤3.0 × ULN.
- QTcF ≤480 msec.
Exclusion criteria
- Prior splenectomy.
- Splenic irradiation within 3 months prior to first dose of study drug.
- Ongoing use of systemic corticosteroids at dose equivalent to \>10mg/day of prednisone.
- Uncontrolled intercurrent illness such as an acute infection.
- Chronic active or acute hepatitis B or C infection.
- Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).
- Use of a Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer).
- Use of erythropoiesis stimulating agents (unless stable for \>8 weeks).
- Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
- Unable or unwilling to undergo CT or MRI for spleen size imaging.
- Pregnant or breastfeeding.
- Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.
Where
- Palo Alto, California
- Tampa, Florida
- Kansas City, Kansas
- Boston, Massachusetts
- Ann Arbor, Michigan
- St Louis, Missouri
- New York, New York
- Charlotte, North Carolina
- Cincinnati, Ohio
- Columbus, Ohio
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations