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RECRUITING
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

2026-03-05

Healthy Volunteers

No

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

Locations (35)

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

Local Institution - 0027

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 - 0047

Lake Success, 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

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

Maastricht UMC+

Maastricht, Limburg, Netherlands

University Medical Center Groningen

Groningen, Netherlands

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