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New treatment option for Primary Myelofibrosis
Official title 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)
ClinicalTrials.gov ID: NCT06343805
What this study is testing
What is AJ1-11095?
AJ1-11095 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Tampa, Florida, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Paris, France
- Bologna, Italy, Italy
- Milan, Italy, Italy
- Madrid, Spain, Spain
- Barcelona, Spain
- Madrid, Spain
- London, UK, United Kingdom
- Oxford, UK, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Tampa, Florida, United States; Kansas City, Kansas, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.