Study on KRT-232 and TKI for Treating Chronic Myeloid Leukemia

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04835584

Provider View

This clinical trial is testing a new oral medication, KRT-232, for patients with Chronic Myeloid Leukemia (CML) who have not responded well to or cannot tolerate Tyrosine Kinase Inhibitors (TKIs).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new oral drug called KRT-232 in treating patients with Chronic Myeloid Leukemia (CML) who have either relapsed or are not responding to Tyrosine Kinase Inhibitors (TKIs). The study is open to patients in the chronic phase (CML-CP) and accelerated phase (CML-AP) of the disease. It is a global study, meaning it includes participants from different countries, and is in Phase 1b/2, which means it is testing both the safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Chronic Myeloid Leukemia in the chronic phase (CML-CP) or accelerated phase (CML-AP) with specific genetic markers (TP53wt, Ph+, BCR-ABL+).
  • Have not responded to or cannot tolerate at least one previous Tyrosine Kinase Inhibitor (TKI) treatment.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood, liver, and kidney function.

Exclusion Criteria

  • Have Chronic Myeloid Leukemia in the accelerated phase (CML-AP) for certain parts of the study.
  • Have Chronic Myeloid Leukemia in the blast crisis phase (CML-BC).
  • Have a known T315I mutation.
  • Have been treated with MDM2 antagonist therapies before.
  • Cannot tolerate current TKI therapy.

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