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JAK2 Inhibitor

AJ1-11095 for Myelofibrosis

Phase 1
Recruiting
Led By John Mascarenhas, M.D.
Research Sponsored by Ajax Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PMF, post-PV MF, or post-ET MF
MFSAF v.4.0 TSS ≥10, or at least 2 of 7 MFSAF-assessed symptoms with scores ≥3
Must not have
Chronic active or acute hepatitis B or C infection
Prior splenectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called AJ1-11095 in people who have myelofibrosis and have already been treated with another type of drug. The trial will look at how safe

Who is the study for?
This trial is for adults with primary or secondary myelofibrosis who didn't respond well to a previous treatment with a type I JAK2 inhibitor. Participants must have certain spleen sizes, symptom scores, and blood counts, as well as an adequate kidney function.
What is being tested?
The study tests AJ1-11095, a new oral medication intended to inhibit JAK2 differently than prior treatments. It's in phase 1 where the focus is on assessing safety, how the body processes it (PK), and its effects on the disease (PD).
What are the potential side effects?
As this is a first-in-human study of AJ1-11095, specific side effects are not yet known but may include typical reactions related to immune system modulation such as fatigue, headaches, dizziness or gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a form of myelofibrosis.
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My symptom scores are high enough to meet the trial's requirements.
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My myelofibrosis is classified as intermediate-2 or high-risk with less than 10% blasts.
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I am 18 years old or older.
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My spleen is enlarged, measuring over 450cm3.
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I can care for myself but may not be fully active.
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I have been treated with a JAK2 inhibitor but did not improve or my condition worsened after initial improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an active hepatitis B or C infection.
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I have had my spleen removed.
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I have not taken a JAK2 inhibitor in the last 10 days.
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I am currently taking more than 10mg/day of steroids.
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I do not have any ongoing serious infections.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I cannot or do not want to have a CT or MRI scan for my spleen.
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I need to take a strong medication that affects liver enzyme levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with Dose Limiting Toxicities (DLTs)
Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0.
To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095
Secondary study objectives
To assess clinical response to AJ1-11095 evaluated by spleen length assessments.
To assess clinical response to AJ1-11095 evaluated by spleen volume assessments.
To assess clinical response to AJ1-11095 evaluated by the Total Symptom Score (TSS).
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort 2Experimental Treatment1 Intervention
Alternative candidate RP2D of AJ1-11095 taken orally by patients.
Group II: Dose Expansion Cohort 1Experimental Treatment1 Intervention
Candidate RP2D of AJ1-11095 taken orally by patients.
Group III: Cohort 5Experimental Treatment1 Intervention
Dose E of AJ1-11095 taken orally by patients.
Group IV: Cohort 4Experimental Treatment1 Intervention
Dose D of AJ1-11095 taken orally by patients.
Group V: Cohort 3Experimental Treatment1 Intervention
Dose C of AJ1-11095 taken orally by patients.
Group VI: Cohort 2Experimental Treatment1 Intervention
Dose B of AJ1-11095 taken orally by patients.
Group VII: Cohort 1Experimental Treatment1 Intervention
Dose A of AJ1-11095 taken orally by patients.

Find a Location

Who is running the clinical trial?

Ajax Therapeutics, Inc.Lead Sponsor
John Mascarenhas, M.D.Principal InvestigatorMt. Sinai
~51 spots leftby Oct 2026
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