Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
Sponsor: Kartos Therapeutics, Inc.
ClinicalTrials ID:NCT04502394
This clinical trial assesses the combination of KRT-232, an oral MDM2 inhibitor, with acalabrutinib, a BTK inhibitor, in adults with TP53wt R/R DLBCL or CLL. Eligible participants must have adequate organ function and an ECOG score of 0-2. Cohort 1 requires R/R DLBCL after ≥2 treatments, or 1 if transplant-ineligible. Cohort 2 requires R/R CLL after ≥1 treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
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)
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
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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