RecruitingRecruiting
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
NCT06090539 · Bristol-Myers Squibb
In plain English
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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)
About this study
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
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.
Study design
Enrollment target: 460 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-29
Estimated completion: 2028-10-28
Last updated: 2026-09-14
Interventions
Drug: BMS-986458Drug: RituximabDrug: Glofitamab/ObinutuzumabDrug: MosunetuzumabDrug: EpcoritamabDrug: Golcadomide
Primary outcomes
- • Number of participants with adverse events (AEs) (Up to 2 years and 1 month)
- • Number of participants with serious adverse events (SAEs) (Up to 2 years and 1 month)
- • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria (Up to Day 28)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (75)
Mayo Clinic in Arizona - PhoenixRecruiting
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
Local Institution - 0068Not Yet Recruiting
Jacksonville, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic in Rochester, MinnesotaRecruiting
Rochester, Minnesota, United States
Local Institution - 0124Not Yet Recruiting
Omaha, Nebraska, United States
Local Institution - 0047Completed
Lake Success, New York, United States
Local Institution - 0037Not Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Local Institution - 0045Not Yet Recruiting
Providence, Rhode Island, United States
Local Institution - 0118Not Yet Recruiting
Antofagasta, AN, Chile
Local Institution - 0105Not Yet Recruiting
Santiago, Metropolitana de Santiago, Chile
Local Institution - 0109Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Beijing Cancer hospitalRecruiting
Beijing, Beijing Municipality, China
Local Institution - 0084Not Yet Recruiting
Guangzhou, Guangdong, China
Local Institution - 0087Not Yet Recruiting
Zhengzhou, Henan, China
Local Institution - 0120Not Yet Recruiting
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Local Institution - 0130Not Yet Recruiting
Nanchang, Jiangxi, China
Local Institution - 0129Not Yet Recruiting
Shenyang, Liaoning, China
Local Institution - 0131Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0128Not Yet Recruiting
Hangzhou, Zhejiang, China
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting
Bordeaux, Aquitaine, France
Local Institution - 0125Not Yet Recruiting
Lyon, Nan, France
Hopital Claude Huriez - CHU de LilleRecruiting
Lille, Nord, France
Gustave RoussyRecruiting
Villejuif, Paris, France
Henri Mondor HospitalRecruiting
Créteil, Val-de-Marne, France
CHU SAINT ELOI - Departement Hematologie CliniqueRecruiting
Montpellier, France
Hôpital Saint-LouisRecruiting
Paris, France
Institut Claudius RegaudRecruiting
Toulouse, France
Universitätsklinikum Münster - Albert Schweitzer CampusRecruiting
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum des SaarlandesRecruiting
Homburg, Saarland, Germany
Universitätsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Helios Klinikum Berlin-BuchRecruiting
Berlin, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Local Institution - 0103Not Yet Recruiting
Pátrai, Achaḯa, Greece
Local Institution - 0107Not Yet Recruiting
Athens, Greece
Local Institution - 0102Not Yet Recruiting
Athens, Greece
Local Institution - 0119Not Yet Recruiting
Hong Kong, Hong Kong
Local Institution - 0094Not Yet Recruiting
Bologna, Italy
Local Institution - 0116Not Yet Recruiting
Brescia, Italy
Local Institution - 0098Not Yet Recruiting
Milan, Italy
Local Institution - 0113Not Yet Recruiting
Milan, Italy
Local Institution - 0112Not Yet Recruiting
Pisa, Italy
Local Institution - 0111Not Yet Recruiting
Ravenna, Italy
Local Institution - 0115Not Yet Recruiting
Roma, Italy
Local Institution - 0110Not Yet Recruiting
Roma, Italy
Local Institution - 0097Not Yet Recruiting
Verona, Italy
Local Institution - 0090Not Yet Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
University of Yamanashi HospitalRecruiting
Chūō, Yamanashi, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Maastricht UMC+Recruiting
Maastricht, Limburg, Netherlands
Local Institution - 0121Not Yet Recruiting
Amsterdam, North Holland, Netherlands
University Medical Center GroningenRecruiting
Groningen, Netherlands
Local Institution - 0077Not Yet Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0123Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0078Not Yet Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Andalusia, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Universitario Fundación Jiménez DíazRecruiting
Madrid, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaRecruiting
Salamanca, Spain
Ospedale Regionale Bellinzona e ValliRecruiting
Bellinzona, Canton Ticino, Switzerland
University Hospital BaselRecruiting
Basel, Switzerland
Hopitaux Universitaires de Geneve (HUG)Recruiting
Geneva, Switzerland
Local Institution - 0096Not Yet Recruiting
Ankara, Turkey (Türkiye)
Local Institution - 0101Not Yet Recruiting
Ankara, Turkey (Türkiye)
Local Institution - 0099Not Yet Recruiting
Istanbul, Turkey (Türkiye)
Local Institution - 0122Not Yet Recruiting
Istanbul, Turkey (Türkiye)
Local Institution - 0071Not Yet Recruiting
Southampton, Hampshire, United Kingdom
Local Institution - 0081Not Yet Recruiting
Manchester, Lancashire, United Kingdom
Local Institution - 0072Not Yet Recruiting
Edinburgh, Midlothian, United Kingdom