A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

Last updated: September 18, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Treatment

BMS-986458

Rituximab

Clinical Study ID

NCT06090539
CA123-1000
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader (LDD) of BCL6 (BCL6 LDD), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥ 18 years of age with R/R NHL (including DLBCL [ie, DLBCL nototherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Celllymphoma with MYC and BCL2 rearrangements], and FL):

  • For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab,anthracycline, an alkylating agent, and steroids and at least one additionaltreatment).

  • For R/R DLBCL (transformed lymphoma): following at least 2 prior lines oftherapy which must have been administered after transformation.

  • For R/R FL (except for FL 3b): following at least 2 prior lines of therapy andmeeting treatment criteria at the time of enrollment based on investigator´sassessment.

  • Participant must have measurable disease (defined by at least one FDG-avid lesionfor FDG-avid disease and one bi-dimensionally measurable disease on cross sectionalimaging by computed tomography or magnetic resonance imaging with at least onelesion > 1.5 cm in the transverse diameter).

  • Participants must accept and follow pregnancy prevention plan.

Exclusion

Exclusion Criteria:

  • Participants must not have an Eastern Cooperative Oncology Group (ECOG) performancestatus ≥ 2.

  • Participants with an inability to comply with listed restrictions, precautions andprohibited treatments.

  • Participants must not have prior CAR-T, Cereblon-modulating drug or radiotherapy ≤ 4weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6months or autologous SCT ≤ 3 months prior to study intervention initiation.

  • Participants must not have any condition, including significant acute or chronicmedical illness, active or uncontrolled infection, or the presence of laboratoryabnormalities, that places participants at unacceptable risk if participating inthis study.

  • Participants must not have known or suspected central nervous system involvement.

Study Design

Total Participants: 273
Treatment Group(s): 2
Primary Treatment: BMS-986458
Phase: 1/2
Study Start date:
December 29, 2023
Estimated Completion Date:
October 28, 2028

Connect with a study center

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord 59000
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, Paris 94800
    France

    Active - Recruiting

  • CHU SAINT ELOI-Département d'Hématologie Clinique

    Montpellier, 34295
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Active - Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, Nordrhein-Westfalen 48149
    Germany

    Active - Recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg, Saarland 66424
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Active - Recruiting

  • Local Institution - 0052

    Maastricht, Limburg 6229 HX
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Active - Recruiting

  • Local Institution - 0054

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Site Not Available

  • Local Institution - 0053

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Local Institution - 0007

    Málaga, Andalucía 29010
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, Ticino 6500
    Switzerland

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaire de Genève

    Genève, 1211
    Switzerland

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 0047

    Lake Success, New York 11042
    United States

    Site Not Available

  • Northwell Health/ RJ Zuckerberg Cancer Center

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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