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

Kartos Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

Treatments: Drug: acalabrutinib; Drug: KRT-232

Study type: Interventional

Funder types: Industry

Identifiers

NCT04502394

KRT-232-111

Details and patient eligibility

About

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)

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Cohort 1 (R/R DLBCL)

Experimental group

Description:

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:

Drug: acalabrutinib

Drug: KRT-232

Cohort 2 (R/R CLL)

Experimental group

Description:

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:

Drug: acalabrutinib

Drug: KRT-232