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

Last updated: August 3, 2022
Sponsor: Kartos Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT04502394
KRT-232-111
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 priorlines 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 priorline of treatment
  • ECOG 0 to 2
  • Adequate hematologic, hepatic, and renal functions.

Exclusion

Exclusion Criteria:

  • Prior treatment with any MDM2 inhibitor
  • Prior treatment with any BTK inhibitor

Study Design

Total Participants: 84
Study Start date:
February 23, 2021
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Eastern Health - Box Hill Hospital

    Box Hill,
    Australia

    Active - Recruiting

  • Barwon Health

    Geelong,
    Australia

    Active - Recruiting

  • Royal Perth Hospital

    Perth,
    Australia

    Active - Recruiting

  • Antwerp University Hospital (UZA)

    Edegem,
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt,
    Belgium

    Active - Recruiting

  • University Hospital (UZ) Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Nový Hradec Králové,
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague,
    Czechia

    Active - Recruiting

  • CHU de Nantes - Hôtel-Dieu

    Nantes,
    France

    Active - Recruiting

  • Centre Henri Becquerel

    Rouen,
    France

    Active - Recruiting

  • CHRU de Tours - Hôpital Bretonneau

    Tours,
    France

    Active - Recruiting

  • Centro Riferimento Oncologico - Aviano

    Aviano,
    Italy

    Active - Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola,
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano,
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona,
    Italy

    Active - Recruiting

  • National Cancer Center

    Goyang,
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdansk,
    Poland

    Active - Recruiting

  • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii

    Gdańsk,
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii

    Gliwice,
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii

    Krakow,
    Poland

    Active - Recruiting

  • Pratia MCM Krakow

    Kraków,
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw,
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga,
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

    Lisboa,
    Portugal

    Active - Recruiting

  • Champalimaud Cancer Center

    Lisbon,
    Portugal

    Active - Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto,
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

    Vila Nova de Gaia,
    Portugal

    Active - Recruiting

  • Kantonsspital St. Gallen

    Saint Gallen,
    Switzerland

    Active - Recruiting

  • St James's University Hospital

    Leeds,
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Royal Marsden Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton,
    United Kingdom

    Active - Recruiting

  • Goshen Center for Cancer Care

    Goshen, Indiana 46526
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45221
    United States

    Active - Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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