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KRT-232 treatment for Chronic Myeloid Leukemia

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

Phase1; Phase2 Interventional Kartos Therapeutics, Inc. · NCT04835584

This study is testing a new oral medication called KRT-232 to see if it can help people with Chronic Myeloid Leukemia who haven't responded well to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment109 (estimated)
Ages18 Years and up
SexAll
SponsorKartos Therapeutics, Inc. Industry-sponsored
Locations26 sites (Birmingham, Alabama and 25 other locations)
Trial IDNCT04835584 on ClinicalTrials.gov

What this trial studies

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for treating patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to Tyrosine Kinase Inhibitors (TKIs). It is a global, open-label Phase 1b/2 trial aimed at determining the efficacy and safety of KRT-232 in patients with chronic phase CML and accelerated phase CML who have failed previous TKI treatments. The study includes multiple treatment arms to assess the drug's performance in different patient populations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented TP53 wild-type, Ph+, BCR-ABL+ chronic phase or accelerated phase CML who have failed at least one prior TKI.

Not a fit: Patients with documented Ph+, BCR-ABL+ blast crisis CML or known T315I mutation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with CML who have limited alternatives due to TKI resistance or intolerance.

How similar studies have performed: Other studies have shown promise with similar approaches targeting MDM2, indicating potential for success in this novel treatment strategy.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP
* Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP
* Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
* Adults ≥ 18 years of age.
* ECOG performance status of 0 to 2
* Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

* Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP
* Documented Ph+, BCR-ABL+ CML-BC
* Known T315I mutation.
* Prior treatment with MDM2 antagonist therapies.
* Intolerance to current TKI therapy.

Where this trial is running

Birmingham, Alabama and 25 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 Chronic Myeloid Leukemianavtemadlin
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.