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Small Molecule Inhibitor

KRT-232 + Acalabrutinib for Blood Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0 to 2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with two types of blood cancer who have not responded to other treatments.

Who is the study for?
This trial is for adults with certain types of blood cancers, specifically Diffuse Large B-Cell Lymphoma (DLBCL) or Chronic Lymphocytic Leukemia (CLL), that have not responded to previous treatments. Participants must be in good general health and have a specific genetic feature in their cancer cells (TP53wt). They should not have had prior treatments with BTK or MDM2 inhibitors.Check my eligibility
What is being tested?
The study tests KRT-232 combined with acalabrutinib on patients who've seen no improvement from other therapies. It's designed to see if this new combination can effectively treat DLBCL and CLL by inhibiting certain proteins that may help these cancers grow.See study design
What are the potential side effects?
Potential side effects include those common to cancer treatments such as nausea, fatigue, and increased risk of infections. Specific side effects related to the drugs being tested could involve changes in blood counts, liver function issues, and possible kidney-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Objective Phase 1b:To determine the KRT-232 maximum tolerated dose/ maximum administered dose (MTD/MAD) and recommended Phase 2 Dose (RP2D) in combination with acalabrutinib in subjects with R/R DLBCL or R/R CLL
Primary Objective Phase 2: Cohort 1: To determine the complete response (CR)
Primary Objective Phase 2: Cohort 2: To determine the rate of CR/complete remission with incomplete hematologic recovery (CRi) rate in R/R CLL
Secondary outcome measures
Phase 1b Secondary Objective: Pharmacokinetic (PK) profile
Phase 2 Secondary Objective: Cohort 1 (R/R DLBCL): To determine the overall response rate (ORR) for R/R DLBCL subjects.
Phase 2 Secondary Objective: Cohort 2 (R/R CLL): To determine the ORR for R/R CLL subjects

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 (R/R CLL)Experimental Treatment2 Interventions
KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
Group II: Cohort 1 (R/R DLBCL)Experimental Treatment2 Interventions
KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
acalabrutinib
2018
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,366 Total Patients Enrolled

Media Library

Acalabrutinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04502394 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Cohort 1 (R/R DLBCL), Cohort 2 (R/R CLL)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04502394 — Phase 1 & 2
Acalabrutinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502394 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled in this research project?

"The clinical trial is seeking participants at this time, according to the information available on clinicaltrials.gov. This particular trial was first posted on February 23rd, 2021 and most recently updated on August 3rd, 2022."

Answered by AI

Is this study taking place in more than one hospital in town?

"5 centres are recruiting patients for this trial, they are The Ohio State University Comprehensive Cancer Center in Dallas, UT Southwestern Medical Center in Goshen, and Goshen Center for Cancer Care in Cincinnati. Additionally, there are 5 other sites."

Answered by AI

How many people are currently taking part in this research project?

"In order to carry out this study, 84 participants that meet the clinical trial's inclusion criteria are needed. The sponsor, Kartos Therapeutics, Inc., will be conducting the trial at locations such as The Ohio State University Comprehensive Cancer Center in Dallas, Texas and UT Southwestern Medical Center in Goshen, Indiana."

Answered by AI

What makes this test unique compared to others like it?

"Presently, there are 88 different ongoing clinical trials for KRT-232 in 564 distinct cities and 51 countries. The very first trial was completed way back in 2014 and was sponsored by Acerta Pharma BV. Out of the 306 patients who participated, the Phase 1 & 2 drug approval stage was completed successfully. In the 6 years since then, 27 more trials have been carried out."

Answered by AI

What is the precedence for KRT-232 research?

"KRT-232 was first researched in 2014 at a designated research site. 27 clinical studies have completed since then. 88 more trials are underway as of now, with many taking place in Dallas, Texas."

Answered by AI

What are the therapeutic benefits of KRT-232?

"KRT-232 is a medication used to manage mantle cell lymphoma (mcl), small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
2021. "Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502394.
~20 spots leftby Apr 2025
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