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Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
RECRUITINGPhase 1/2Sponsored by Kartos Therapeutics, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorKartos Therapeutics, Inc.
Started2021-02-23
Est. completion2022-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT04502394
Summary
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
CancerChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaNon-hodgkin Lymphoma
Interventions2
Locations4 sites
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Actively Recruiting
PhasePhase 1/2
SponsorKartos Therapeutics, Inc.
Started2021-02-23
Est. completion2022-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT04502394