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A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Sponsor: Bristol-Myers Squibb
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
460
Start Date
2023-12-29
Completion Date
2028-10-28
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
BMS-986458
Specified dose on specified days.
Rituximab
Specified dose on specified days.
Glofitamab/Obinutuzumab
Specified dose on specified days
Mosunetuzumab
Specified dose on specified days
Epcoritamab
Specified dose on specified days
Golcadomide
Specified dose on specified days
Locations (67)
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 - 0089
Nanchang, Jiangxi, 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
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 - 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
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 - 0123
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0077
Seoul, Seoul Teugbyeolsi, 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 - 0071
Southampton, Hampshire, United Kingdom
Local Institution - 0081
Manchester, Lancashire, United Kingdom
Local Institution - 0072
Edinburgh, Midlothian, United Kingdom