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New hope for myelofibrosis patients: experimental pill targets resistant disease

NCT ID NCT06343805

Disease control Sponsor: Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This early-stage study tests an experimental oral drug, AJ1-11095, in about 76 adults with myelofibrosis (a type of bone marrow cancer) whose disease has stopped responding to standard JAK2 inhibitor therapy. The main goals are to check the drug's safety, find the best dose, and see if it can reduce symptoms and spleen size. Participants must have moderate-to-high risk disease and significant symptoms or spleen enlargement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of PMF, post-PV MF, or post-ET MF. * Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status. * Estimated spleen volume greater than or equal to (≥)450 cubic centimeter (cm ³) * Myelofibrosis Symptom Assessment Form, version 4.0 (MFSAF v.4.0) TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3. * Eastern Cooperative Oncology Group performance score (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. * Absolute neutrophil count greater than or equal to 1,000 per microliter of blood (ANC ≥1.0×10\^9/L). * Platelet count ≥75×10\^9/L. * Estimated glomerular filtration rate greater than or equal to 45 milliliters per minute per 1.73 square meters (eGFR ≥45 mL/min/1.73m²). * Serum total bilirubin ≤2.0 × upper limit of normal (ULN). * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit normal (ULN). * QTcF ≤470 msec. Polycythemia vera (PV) Only * Confirmed diagnosis of PV * Participants must have high-risk disease as defined by 60 years of age or older and/or have prior history of thrombotic event * R/R or intolerant to at least one line of prior therapy including but not limited to interferon-based therapies, ruxolitinib, or hydroxyurea (HU) as defined by European LeukemiaNet (ELN) criteria Exclusion Criteria: * Prior splenectomy or splenic irradiation within 3 months. * Ongoing use of systemic corticosteroids at dose equivalent to greater than (\>) 20 milligrams per day (mg/day) of prednisone. * Active, uncontrolled systemic infection or active Hepatitis B or C * Chemotherapy in the previous 4 weeks or prior JAK2 inhibitor not discontinued per required washout prior to first dose * Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0). * Pregnant or breastfeeding: males planning to father a child during treatment and for 3 months after last dose. * Requirement for therapy with a medication that is a strong Cytochrome P450 3A4 CYP3A4 inhibitor as a concomitant medication. * Currently on an interventional therapeutic trial in the treatment phase. * Significant cardiovascular disease * Active second primary malignancy (or diagnosed within 2 years) at high risk of progression, with standard exceptions (treated skin cancer, in situ cervical cancer, curatively treated localized breast/prostate cancer) * Prolongation of the corrected QTcF ≥470 millisecond during screening * Individual with a history of (noninfectious) pneumonitis/interstitial lung disease. First line (1L) MF only: * Prior treatment with JAK2 inhibitors High-risk R/R PV only: * Prior PV-directed therapy without required washout * Active or chronic bleeding within 2 months prior to enrollment * Clinically significant thrombosis (e.g., pulmonary embolism, deep vein thrombosis, or splenic vein thrombosis) within 2 months prior to enrollment * Requires phlebotomy at hematocrit levels \<45%.

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera platelet membrane fluidity primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pet-MF PMF Post-essential thrombocythemia myelofibrosis Post-polycythemia vera myelofibrosis PPV-MF Primary myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Hopital Saint-Louis

    RECRUITING

    Paris, France

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10021, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Italy, Italy

  • Genesis Cancer Care UK Limited - Oxford

    NOT_YET_RECRUITING

    Oxford, UK, United Kingdom

  • Guy's Hospital

    NOT_YET_RECRUITING

    London, UK, United Kingdom

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, Spain, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

    NOT_YET_RECRUITING

    Bologna, Italy, Italy

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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