NCT06343805 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)
| NCT ID | NCT06343805 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ajax Therapeutics, Inc. |
| Condition | Primary Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2024-10-23 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 Type I JAK2 inhibitor must have been discontinued for at least 5 days or 5 half-lives prior to dosing (whichever is longer). 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.
Contact & Investigator
John Mascarenhas, M.D.
PRINCIPAL INVESTIGATOR
Mt. Sinai
Frequently Asked Questions
Who can join the NCT06343805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343805 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06343805 currently recruiting?
Yes, NCT06343805 is actively recruiting participants. Contact the research team at david@ajaxtherapeutics.com for enrollment information.
Where is the NCT06343805 trial being conducted?
This trial is being conducted at Palo Alto, United States, Tampa, United States, Kansas City, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT06343805 clinical trial?
NCT06343805 is sponsored by Ajax Therapeutics, Inc.. The principal investigator is John Mascarenhas, M.D. at Mt. Sinai. The trial plans to enroll 76 participants.