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Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* Prior treatment with any MDM2 inhibitor
* Prior treatment with any BTK inhibitor

About the study

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

What is being tested

Sponsor: Kartos Therapeutics, Inc. · Participants: 84 · Started: Feb 23, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04502394

Locations in the U.S.

IndianaGoshen Center for Cancer Care, Goshen
OhioUniversity of Cincinnati, Cincinnati
The Ohio State University Comprehensive Cancer Center, Columbus
TexasUT Southwestern Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.