RecruitingPhase 1Phase 2NCT06090539

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

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)

Sponsor

Bristol-Myers Squibb

Enrollment

308 participants

Start Date

Dec 29, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BMS-986458, alone or combined with standard anti-lymphoma therapies, for people with relapsed or refractory non-Hodgkin lymphoma (blood cancer that has returned or stopped responding to treatment). The goal is to determine the right dose and assess how well the drug works. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory DLBCL (including transformed) or follicular lymphoma - You have received at least 2 prior lines of treatment, including standard chemoimmunotherapy - You have measurable disease on imaging (CT or MRI/PET) - Your organ function is within acceptable limits **You may NOT be eligible if...** - You have received prior CAR-T therapy (for certain parts of the study) - You have active CNS lymphoma - You have significant cardiac, liver, or kidney dysfunction - You are pregnant or breastfeeding - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986458

Specified dose on specified days.

DRUGRituximab

Specified dose on specified days.

DRUGGlofitamab/Obinutuzumab

Specified dose on specified days

DRUGMosunetuzumab

Specified dose on specified days

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

View Full Details on ClinicalTrials.gov

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NCT06090539

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