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Evaluating KRT-232 or TL-895 for treatment-naïve myelofibrosis patients

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Phase 2 Interventional Kartos Therapeutics, Inc. · NCT04878003

This study is testing two new drugs, KRT-232 and TL-895, to see if they can safely help people with myelofibrosis who haven't received treatment before.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment52 (estimated)
Ages18 Years and up
SexAll
SponsorKartos Therapeutics, Inc. Industry-sponsored
Locations29 sites (Glendale, California and 28 other locations)
Trial IDNCT04878003 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, and efficacy of two investigational drugs, KRT-232 and TL-895, in patients with treatment-naïve myelofibrosis, including primary myelofibrosis and post-polycythemia vera or essential thrombocythemia myelofibrosis. The trial is structured in two stages, with the first stage focusing on initial evaluations and the second stage expanding enrollment based on predefined criteria. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with primary myelofibrosis or post-polycythemia vera or essential thrombocythemia myelofibrosis who are treatment-naïve and classified as high-risk or intermediate risk.

Not a fit: Patients who have previously received treatment with any JAK inhibitors or have specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with myelofibrosis who have not yet received therapy.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in targeting myelofibrosis with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
* High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
* ECOG of 0 or 1

Exclusion Criteria:

* Subjects who are positive for p53 mutation (Arm 1)
* Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
* Prior treatment with any JAK inhibitor
* Prior splenectomy
* Splenic irradiation within 24 weeks prior to randomization
* Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation
* Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Where this trial is running

Glendale, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary MyelofibrosisPost-Polycythemia Vera MyelofibrosisPost-Essential Thrombocythemia Myelofibrosisnavtemadlin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.