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)
Launched by AJAX THERAPEUTICS, INC. · Mar 26, 2024
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called AJ1-11095 for patients with specific types of myelofibrosis, which is a serious blood disorder affecting the bone marrow. The trial is designed for adults aged 18 and older who have already tried a different treatment but did not have a good response or their condition got worse. To be eligible, participants should have a diagnosis of primary myelofibrosis or myelofibrosis that developed after having other blood conditions like polycythemia vera or essential thrombocythemia. They also need to have certain symptoms and characteristics, such as a larger-than-normal spleen and specific risk factors related to their condition.
In this trial, participants will receive the new oral medication and will be monitored for its safety and effectiveness, as well as how their bodies process the drug. The study is currently recruiting, and participants can expect regular check-ups and tests to assess their health and response to the treatment. It's important to note that there are some restrictions, like not having had certain treatments recently, so potential participants should discuss their medical history with their doctor to see if they qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 18 years of age or older.
- • 2. Diagnosis of PMF, post-PV MF, or post-ET MF.
- • 3. DIPSS Intermediate-2 or High-risk MF with ≤10% blasts, regardless of JAK2 mutation status.
- • 4. Estimated spleen volume ≥450cm3.
- • 5. MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3.
- • 6. ECOG PS of 0, 1, 2, or 3.
- • 7. Prior therapy with at least 1 type I JAK2 inhibitor, and either failed to achieve a response or relapsed after achieving a response.
- • 8. ANC ≥1.0×10\^9/L.
- • 9. Platelet count ≥75×10\^9/L.
- • 10. eGFR ≥45 mL/min/1.73m2.
- • 11. Serum total bilirubin ≤2.0 × upper limit of normal (ULN).
- • 12. AST and ALT ≤3.0 × ULN.
- • 13. QTcF ≤480 msec.
- Exclusion Criteria:
- • 1. Prior splenectomy.
- • 2. Splenic irradiation within 3 months prior to first dose of study drug.
- • 3. Ongoing use of systemic corticosteroids at dose equivalent to \>10mg/day of prednisone.
- • 4. Uncontrolled intercurrent illness such as an acute infection.
- • 5. Chronic active or acute hepatitis B or C infection.
- • 6. Chemotherapy in the previous 4 weeks prior to first dose of study drug (Hydrea is permitted until 5 days before starting protocol therapy).
- • 7. Use of a JAK2 inhibitor in the previous 10 days.
- • 8. Use of erythropoiesis stimulating agents (unless stable for \>8 weeks).
- • 9. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v 5.0).
- • 10. Unable or unwilling to undergo CT or MRI for spleen size imaging.
- • 11. Pregnant or breastfeeding.
- • 12. Requirement for therapy with a medication that is a strong CYP3A4 inhibitor as a concomitant medication.
About Ajax Therapeutics, Inc.
Ajax Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to advancing innovative therapies for unmet medical needs. With a strong focus on developing novel treatments in areas such as oncology, autoimmune disorders, and rare diseases, Ajax Therapeutics integrates cutting-edge research with a commitment to patient-centric solutions. The company leverages state-of-the-art technology and expertise in drug development to streamline the clinical trial process, ensuring that promising therapies reach the market efficiently and safely. Through collaboration with leading healthcare professionals and institutions, Ajax Therapeutics aims to transform patient care and improve health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Cincinnati, Ohio, United States
New York, New York, United States
Palo Alto, California, United States
Charlotte, North Carolina, United States
Kansas City, Kansas, United States
Columbus, Ohio, United States
New York, New York, United States
Tampa, Florida, United States
Patients applied
Trial Officials
John Mascarenhas, M.D.
Principal Investigator
Mt. Sinai
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported