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NCT06090539PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

12/29/2023

Completion Date

10/28/2028

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986458

DRUG

Rituximab

DRUG

Glofitamab/Obinutuzumab

DRUG

Mosunetuzumab

DRUG

Epcoritamab

DRUG

Golcadomide

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Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

Locations

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona 85054

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Local Institution - 0068

Jacksonville, Florida 32224

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

Local Institution - 0124

Omaha, Nebraska 68105

United States

Local Institution - 0047

Lake Success, New York 11042

United States

Local Institution - 0037

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Local Institution - 0045

Providence, Rhode Island 02903

United States

Local Institution - 0118

Antofagasta, AN 1240000

Chile

Local Institution - 0105

Santiago, Metropolitana de Santiago 7580206

Chile

Local Institution - 0109

Santiago, Santiago Metropolitan 8420383

Chile

Beijing Cancer hospital

Beijing, Beijing Municipality 100142

China

Local Institution - 0084

Guangzhou, Guangdong 510555

China

Local Institution - 0087

Zhengzhou, Henan 450008

China

Local Institution - 0089

Nanchang, Jiangxi 330006

China

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine 33076

France

Local Institution - 0125

Lyon, Nan 69373

France

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59000

France

Gustave Roussy

Villejuif, Paris 94800

France

Henri Mondor Hospital

Créteil, Val-de-Marne 94010

France

CHU SAINT ELOI - Departement Hematologie Clinique

Montpellier, 34295

France

Hôpital Saint-Louis

Paris, 75010

France

Institut Claudius Regaud

Toulouse, 31059

France

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia 48149

Germany

Universitaetsklinikum des Saarlandes

Homburg, Saarland 66424

Germany

Universitätsklinikum Leipzig

Leipzig, Saxony 04103

Germany

Helios Klinikum Berlin-Buch

Berlin, 13125

Germany

Local Institution - 0070

Essen, 45147

Germany

Local Institution - 0103

Pátrai, Achaḯa 26504

Greece

Local Institution - 0106

Alexandroupoli, Evros 68100

Greece

Local Institution - 0107

Athens, 10676

Greece

Local Institution - 0102

Athens, 11 527

Greece

Local Institution - 0119

Hong Kong, 0

Hong Kong

Local Institution - 0094

Bologna, 40138

Italy

Local Institution - 0116

Brescia, 25123

Italy

Local Institution - 0098

Milan, 20132

Italy

Local Institution - 0113

Milan, 20133

Italy

Local Institution - 0112

Pisa, 56126

Italy

Local Institution - 0111

Ravenna, 48121

Italy

Local Institution - 0115

Roma, 00144

Italy

Local Institution - 0110

Roma, 00168

Italy

Local Institution - 0097

Verona, 37134

Italy

Local Institution - 0090

Nagoya, Aichi-ken 4668560

Japan

Local Institution - 0091

Chuo-ku, Tokyo 104-0045

Japan

Local Institution - 0086

Chūō, Yamanashi 4093898

Japan

Local Institution - 0092

Fukuoka, 812-8582

Japan

Maastricht UMC+

Maastricht, Limburg 6229 HX

Netherlands

Local Institution - 0121

Amsterdam, North Holland 1981 HV

Netherlands

University Medical Center Groningen

Groningen, 9713 GZ

Netherlands

Local Institution - 0123

Seoul, Seoul Teugbyeolsi 03080

South Korea

Local Institution - 0077

Seoul, Seoul Teugbyeolsi 06351

South Korea

Local Institution - 0078

Seoul, Seoul-teukbyeolsi 05505

South Korea

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia 29010

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de 28009

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007

Spain

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino 6500

Switzerland

University Hospital Basel

Basel, 4031

Switzerland

Hopitaux Universitaires de Geneve (HUG)

Geneva, 1205

Switzerland

Local Institution - 0071

Southampton, Hampshire SO16 0YD

United Kingdom

Local Institution - 0081

Manchester, Lancashire M20 4BX

United Kingdom

Local Institution - 0072

Edinburgh, Midlothian EH4 2XU

United Kingdom