RECRUITING

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)

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Multicenter, Open-Label, Phase 1 Study of AJ1-11095 Administered as Oral Monotherapy 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)

Quick Facts

Study Start:2024-10-23

Study Completion:2027-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06343805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

David Steensma, M.D.

CONTACT

917-410-7250

david@ajaxtherapeutics.com

Principal Investigator

John Mascarenhas, M.D.

PRINCIPAL_INVESTIGATOR

Mt. Sinai

Study Locations (Sites)

Moffitt Cancer Cancer Center

Tampa, Florida, 33612

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

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

New York, New York, 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

University of Cincinnati

Cincinnati, Ohio, 45221

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ajax Therapeutics, Inc.

John Mascarenhas, M.D., PRINCIPAL_INVESTIGATOR, Mt. Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23

Study Completion Date2027-02-15

Study Record Updates

Study Start Date2024-10-23

Study Completion Date2027-02-15

Terms related to this study

Additional Relevant MeSH Terms

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