KRT-232 plus acalabrutinib in relapsed/refractory DLBCL or CLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines KRT-232, an oral MDM2 inhibitor, with acalabrutinib in adults with relapsed or refractory Diffuse Large B-Cell Lymphoma or Chronic Lymphocytic Leukemia. It includes two cohorts: TP53-wildtype DLBCL and TP53-wildtype CLL, each with specific prior therapy requirements. Participants must have adequate organ function and an ECOG performance status of 0 to 2, and those previously treated with MDM2 inhibitors or BTK inhibitors are excluded. The study spans Phase 1 and Phase 2 to assess safety, tolerability, and preliminary efficacy of the combination. Lead sites are in Indiana and Ohio, with Kartos Therapeutics, Inc. as the sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Goshen Center for Cancer Care
  Goshen, Indiana, United States Recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting
• The Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Royal Adelaide Hospital
  Adelaide, Australia Recruiting
• Eastern Health - Box Hill Hospital
  Box Hill, Australia Recruiting

Study contacts

• Study coordinator: John Mei
• Email: jmei@kartosthera.com
• Phone: 650-542-0136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.