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JAK2 Inhibitor

Cohort 2 for Primary Myelofibrosis

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Ajax Therapeutics, Inc.Lead Sponsor

John Mascarenhas, M.D.Principal InvestigatorMt. Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants for this clinical study?

"According to information on clinicaltrials.gov, this particular research endeavor is not currently in the recruitment phase. Its initial posting date was recorded as July 15th, 2024 and the most recent update occurred on April 17th, 2024. While this study is presently inactive regarding participant enrollment, it's worth noting that there are a total of 119 other clinical trials actively seeking candidates for involvement at the moment."

Answered by AI

What are the primary goals and objectives of this medical study?

"The main focus of this study, spanning from baseline to the projected completion in approximately 1 year, is to track the incidence of treatment-related adverse events using CTCAE v5.0 criteria. Additional objectives involve assessing AJ1-11095's Tmax (time taken to reach peak concentration), half-life (depletion rate within the body over time), and Cmax (peak plasma concentration)."

Answered by AI

Has Cohort 5 been officially sanctioned by the FDA?

"Our team at Power has rated the safety of Cohort 5 as a 1 on our scale, reflecting that this Phase 1 trial has scarce data supporting both efficacy and safety."

Answered by AI

How widespread is the participation of hospitals in this clinical study within the United States?

"Recruitment is ongoing at various medical centers, such as Massachusetts General Hospital in Kansas City, University of Kansas Medical Center in Tampa, and Moffitt Cancer Center located in Saint Louis. Additionally, there are nine more sites participating in patient recruitment for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2024. "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. https://clinicaltrials.gov/ct2/show/NCT06343805.

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