Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Description

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Conditions

Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

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Study Overview

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Study Details

Study overview

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

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

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Condition
Primary Myelofibrosis (PMF)
Intervention / Treatment

-

Contacts and Locations

Glendale

Innovative Clinical Research Institute, Glendale, California, United States, 90603

Whittier

Innovative Clinical Research Institute, Whittier, California, United States, 90603

Canton

Gabrail Cancer Center, Canton, Ohio, United States, 44718

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kartos Therapeutics, Inc.,

Study Record Dates

2025-10