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RecruitingLast updated: 6 October 2023

This phase I/II trial is evaluating the effectiveness of a new targeted therapy (KRT-232) combined with another targeted therapy (acalabrutinib) in people with relapsed or refractory diffuse large B-cell lymphoma and chronic lymphocytic leukaemiaAn Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

Clinical summary

Summary

This is a non-randomised, open-label trial with two experimental cohorts. Experimental Cohort 1 is made up of participants with relapsed or refractory diffuse large B-cell lymphoma, and Experimental Cohort 2 is made up of relapsed or refractory chronic lymphocytic leukaemia. Both cohorts will receive KRT-232 and Acalabrutinib. KRT-232 will be administered orally, once daily, on days 1-7 in a 28-day cycle. Acalabrutinib will be administered 100mg, twice daily, continuously starting on Day 1 in a 28-day cycle.

Conditions

This trial is treating patients with relapsed or refractory diffuse large B-cell lymphoma and chronic lymphocytic leukaemia.

Cancer

Blood Cancers Blood

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Commercial Sponsor

Kartos Therapeutics, Inc.

Scientific Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

Eligibility

Inclusion

  • Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant
  • Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment
  • ECOG 0 to 2
  • Adequate hematologic, hepatic, and renal functions.

Exclusion

  • Prior treatment with any MDM2 inhibitor
  • Prior treatment with any BTK inhibitor

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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