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NCT06090539

PHASE1/PHASE2

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2023-12-29

Completion Date

2028-10-28

Last Updated

2026-04-14

Healthy Volunteers

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

Interventions

DRUG

BMS-986458

Specified dose on specified days.

DRUG

Rituximab

Specified dose on specified days.

DRUG

Glofitamab/Obinutuzumab

Specified dose on specified days

DRUG

Mosunetuzumab

Specified dose on specified days

Inclusion Criteria: * Participants ≥ 18 years of age with R/R NHL (including DLBCL \[ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements\], 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 additional treatment). * For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation. * For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment. * 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.

Locations (65)

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

Local Institution - 0014

Fairway, Kansas, 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 - 0040

Pittsburgh, Pennsylvania, United States

Local Institution - 0045

Providence, Rhode Island, United States

Local Institution - 0024

Milwaukee, Wisconsin, United States

Local Institution - 0118

Antofagasta, AN, Chile

Local Institution - 0105

Santiago, Metropolitana de Santiago, Chile

Local Institution - 0109

Santiago, Santiago Metropolitan, Chile

Local Institution - 0088

Beijing, Beijing Municipality, China

Local Institution - 0089

Nanchang, Jiangxi, China

Local Institution - 0084

Guangzhou, China

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

Bordeaux, Aquitaine, 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

Local Institution - 0070

Essen, Germany

Local Institution - 0103

Pátrai, Achaḯa, Greece

Local Institution - 0106

Alexandroupoli, Evros, Greece

Local Institution - 0107

Athens, Greece

Local Institution - 0102

Athens, Greece

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

Local Institution - 0091

Chuo-ku, Tokyo, Japan

Local Institution - 0086

Chūō, Yamanashi, Japan

Local Institution - 0092

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

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0069

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 - 0071

Southampton, Hampshire, United Kingdom

Local Institution - 0081

Manchester, Lancashire, United Kingdom

Local Institution - 0072

Edinburgh, Midlothian, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)