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OncoMatch/Clinical Trials/NCT04835584

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Is NCT04835584 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including KRT-232 and Dasatinib for chronic myeloid leukemia.

Phase 1/2RecruitingKartos Therapeutics, Inc.NCT04835584Data as of Jun 2026Location: International · 8 countries

Treatment: KRT-232 · Dasatinib · NilotinibThis study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

DasatinibNilotinib

Other

KRT-232

Cancer type

Chronic Myeloid Leukemia

Biomarker criteria

Required: TP53 wild-type

Documented TP53wt

Required: BCR ABL1 fusion

BCR-ABL+

Required: ABL1 BCR fusion

BCR-ABL+

Excluded: ABL1 T315I

Known T315I mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: bcr-abl inhibitor

Cannot have received: mdm2 antagonist

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama Birmingham · Birmingham, Alabama
  • Georgia Cancer Center at Augusta University · Augusta, Georgia
  • University of Pittsburgh Medical Center · Pittsburgh, Pennsylvania
  • Texas Oncology- Sammons CC at Baylor · Dallas, Texas
  • Medical College of Wisconsin · Milwaukee, Wisconsin

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04835584 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior mdm2 antagonist disqualifies patients from enrollment.

Does this trial require TP53?

Yes, TP53 wild-type is a required biomarker for enrollment.

Does this trial require BCR?

Yes, BCR ABL1 fusion is a required biomarker for enrollment.

Does this trial require ABL1?

Yes, ABL1 BCR fusion is a required biomarker for enrollment.

Are patients with ABL1 alterations eligible?

No. ABL1 T315I is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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