Study on the Safety and Effectiveness of KRT-232 with Acalabrutinib for Treating Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT04502394

This clinical trial is testing a new combination of drugs, KRT-232 and acalabrutinib, to see if they are safe and effective for adults with Diffuse Large B-Cell Lymphoma (DLBCL) or Chronic Lymphocytic Leukemia (CLL) that has returned or not responded to previous treatments.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to evaluate a new treatment using KRT-232, an oral medication, combined with acalabrutinib for adults with Diffuse Large B-Cell Lymphoma (DLBCL) and Chronic Lymphocytic Leukemia (CLL) that have either come back or not responded to earlier treatments. Participants in this study must have previously tried other therapies without success.

Eligibility Criteria

Inclusion Criteria

For DLBCL patients: Must have a confirmed diagnosis of TP53wt Diffuse Large B-Cell Lymphoma and have tried at least two previous treatments, or one if not eligible for a stem cell transplant.
For CLL patients: Must have a confirmed diagnosis of TP53wt Chronic Lymphocytic Leukemia and have tried at least one previous treatment.
Must be in relatively good health with an ECOG performance status score between 0 and 2.
Must have adequate blood, liver, and kidney function.

Exclusion Criteria

Have previously been treated with any MDM2 inhibitor.
Have previously been treated with any BTK inhibitor.

Locations

FACILITY	ZIP	CITY	STATE
Goshen Center for Cancer Care	46526	Goshen	Indiana
University of Cincinnati	45221	Cincinnati	Ohio
The Ohio State University Comprehensive Cancer Center	43210	Columbus	Ohio
UT Southwestern Medical Center	75390	Dallas	Texas

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