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

Last updated: July 2, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Treatment

Mosunetuzumab

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 of B-cell lymphoma 6 (BCL6), 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, or radiotherapy ≤ 4 weeks, systemicanticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (onlyapplicable to BMS-986458 single agent or rituximab combination cohorts), orautologous SCT ≤ 3 months prior to study intervention initiation.

  • In BMS-986458 + T-cell engager combination cohorts: Participants must not have prioralloSCT or solid organ transplantation, history of confirmed progressive multifocalleukoencephalopathy (PML); known or suspected history of hemophagocyticlymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV)infection.

  • 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: 308
Treatment Group(s): 4
Primary Treatment: Mosunetuzumab
Phase: 1/2
Study Start date:
December 29, 2023
Estimated Completion Date:
October 28, 2028

Connect with a study center

  • Local Institution - 0057

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord 59000
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, Paris 94800
    France

    Active - Recruiting

  • CHU SAINT ELOI - Departement Hematologie Clinique

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU SAINT ELOI-Département d'Hématologie Clinique

    Montpellier, 34295
    France

    Active - Recruiting

  • Local Institution - 0058

    Paris, 75010
    France

    Site Not Available

  • 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

    Malaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalucía 29010
    Spain

    Site Not Available

  • Local Institution - 0007

    Málaga, Andalucía 29010
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0069

    Madrid, Madrid, Comunidad De 28009
    Spain

    Site Not Available

  • 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

  • Hopitaux Universitaires de Geneve (HUG)

    Geneve, 1205
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaire de Genève

    Genève, 1211
    Switzerland

    Site Not Available

  • Local Institution - 0067

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Local Institution - 0027

    Tampa, Florida 33612
    United States

    Site Not Available

  • Local Institution - 0014

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 0066

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • 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

  • Local Institution - 0040

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

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