RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Bristol-Myers Squibb • ClinicalTrials.gov ID: NCT06090539

Registry updated: 2026-09-14

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Description

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.

Interventions

BMS-986458 (Drug)
Specified dose on specified days.
Rituximab (Drug)
Specified dose on specified days.
Glofitamab/Obinutuzumab (Drug)
Specified dose on specified days
Mosunetuzumab (Drug)
Specified dose on specified days
Epcoritamab (Drug)
Specified dose on specified days
Golcadomide (Drug)
Specified dose on specified days

Eligibility criteria

Inclusion Criteria: * Participants ≥ 18 years of age with frontline or R/R NHL. * Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \> 1.5 cm in the transverse diameter). * Participants must accept and follow pregnancy prevention plan. Exclusion Criteria: * Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2. * Participants with an inability to comply with listed restrictions, precautions and prohibited treatments. * Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation. * In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection. * Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. * Participants must not have known or suspected central nervous system involvement. * Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

Locations

Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Local Institution - 0068 — Jacksonville, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
Local Institution - 0124 — Omaha, Nebraska, United States
Local Institution - 0047 — Lake Success, New York, United States
Local Institution - 0037 — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Local Institution - 0045 — Providence, Rhode Island, United States
Local Institution - 0118 — Antofagasta, AN, Chile
Local Institution - 0105 — Santiago, Metropolitana de Santiago, Chile
Local Institution - 0109 — Santiago, Santiago Metropolitan, Chile
Beijing Cancer hospital — Beijing, Beijing Municipality, China
Local Institution - 0084 — Guangzhou, Guangdong, China
Local Institution - 0087 — Zhengzhou, Henan, China
Local Institution - 0120 — Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
Local Institution - 0130 — Nanchang, Jiangxi, China
Local Institution - 0129 — Shenyang, Liaoning, China
Local Institution - 0131 — Shanghai, Shanghai Municipality, China
Local Institution - 0128 — Hangzhou, Zhejiang, China
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, Aquitaine, France
Local Institution - 0125 — Lyon, Nan, France
Hopital Claude Huriez - CHU de Lille — Lille, Nord, France
Gustave Roussy — Villejuif, Paris, France
Henri Mondor Hospital — Créteil, Val-de-Marne, France
CHU SAINT ELOI - Departement Hematologie Clinique — Montpellier, France
Hôpital Saint-Louis — Paris, France
Institut Claudius Regaud — Toulouse, France
Universitätsklinikum Münster - Albert Schweitzer Campus — Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes — Homburg, Saarland, Germany
Universitätsklinikum Leipzig — Leipzig, Saxony, Germany
Helios Klinikum Berlin-Buch — Berlin, Germany
Universitaetsklinikum Essen — Essen, Germany
Local Institution - 0103 — Pátrai, Achaḯa, Greece
Local Institution - 0107 — Athens, Greece
Local Institution - 0102 — Athens, Greece
Local Institution - 0119 — Hong Kong, Hong Kong
Local Institution - 0094 — Bologna, Italy
Local Institution - 0116 — Brescia, Italy
Local Institution - 0098 — Milan, Italy
Local Institution - 0113 — Milan, Italy
Local Institution - 0112 — Pisa, Italy
Local Institution - 0111 — Ravenna, Italy
Local Institution - 0115 — Roma, Italy
Local Institution - 0110 — Roma, Italy
Local Institution - 0097 — Verona, Italy
Local Institution - 0090 — Nagoya, Aichi-ken, Japan
National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
University of Yamanashi Hospital — Chūō, Yamanashi, Japan
Kyushu University Hospital — Fukuoka, Japan
Maastricht UMC+ — Maastricht, Limburg, Netherlands
Local Institution - 0121 — Amsterdam, North Holland, Netherlands
University Medical Center Groningen — Groningen, Netherlands
Local Institution - 0077 — Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0123 — Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0078 — Seoul, Seoul-teukbyeolsi, South Korea
Hospital Universitario Virgen de la Victoria — Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain
Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra — Pamplona, Navarre, Spain
Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca, Spain
Ospedale Regionale Bellinzona e Valli — Bellinzona, Canton Ticino, Switzerland
University Hospital Basel — Basel, Switzerland
Hopitaux Universitaires de Geneve (HUG) — Geneva, Switzerland
Local Institution - 0096 — Ankara, Turkey (Türkiye)
Local Institution - 0101 — Ankara, Turkey (Türkiye)
Local Institution - 0099 — Istanbul, Turkey (Türkiye)
Local Institution - 0122 — Istanbul, Turkey (Türkiye)
Local Institution - 0071 — Southampton, Hampshire, United Kingdom
Local Institution - 0081 — Manchester, Lancashire, United Kingdom
Local Institution - 0072 — Edinburgh, Midlothian, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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